Augmentin is a brand-name prescription antibiotic medication. It’s used to treat infections caused by bacteria. Augmentin belongs to the penicillin class of antibiotics.

Augmentin contains two drugs: amoxicillin and clavulanic acid. This combination makes Augmentin work against more types of bacteria than antibiotics that contain amoxicillin alone.

Augmentin is effective for treating infections caused by many different types of bacteria. These include bacteria that cause:

Augmentin comes in two forms, both of which are taken by mouth:

  • tablets
  • liquid suspension

Augmentin can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Augmentin. This list does not include all possible side effects.

For more information on the possible side effects of Augmentin, or for tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

Mild and more common side effects

The more common side effects of Augmentin include:

  • diarrhea
  • nausea
  • skin rash*
  • vaginitis (caused by problems such as yeast infection)
  • vomiting

Other mild side effects reported in clinical trials included:

  • abdominal discomfort
  • gas
  • headache

These side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about this side effect, see “Side effect details” below.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

  • Liver problems. It’s not common, but some people who take Augmentin can develop liver damage. This seems to be more common in older adults and those who take Augmentin for a long time. Usually these problems go away when the medication is stopped, but in some cases, they may be severe and require treatment. Tell your doctor if you develop symptoms of liver problems while taking Augmentin. Your doctor may do blood tests to check for liver damage. Symptoms can include:
    • abdominal pain
    • fatigue
    • yellowing of your skin or the whites of your eyes
  • Intestinal infection. Some people who take antibiotics, including Augmentin, can develop an intestinal infection called Clostridioides difficile (C. diff). Tell your doctor if you develop symptoms of this infection. Symptoms can include:
    • severe diarrhea that doesn’t go away
    • abdominal pain or cramping
    • nausea
    • blood in your stool
  • Severe skin reactions. Serious skin reactions can occur with Augmentin treatment. These reactions can include Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Symptoms of a severe skin reaction can include:
    • red or discolored skin rash
    • blisters and skin peeling
    • fever
    • flu-like symptoms
  • Allergic reaction. Serious allergic reactions can occur in some people who take Augmentin. This is more likely to happen in people with a penicillin allergy. You may not be able to take this medication again if you’ve ever had a serious allergic reaction to it. Taking it again could be fatal. If you’ve had a reaction to this medication in the past, talk with your doctor before taking it again. Symptoms of an allergic reaction can include:
    • severe skin rash
    • hives
    • swelling of the lips, tongue, throat
    • trouble breathing

Side effect details

Below are details about some of Augmentin’s side effects. In addition to the information above, you can also refer to this article for details about Augmentin’s side effects.


Many medications, including Augmentin, can cause a rash in some people. This is a common side effect of Augmentin, which is a penicillin-type antibiotic. This class of antibiotics causes skin rash more often than most other kinds of antibiotics.

Rash occurs in about 3% of people who take Augmentin. In rare cases, serious skin reactions can occur, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). See the list of “Serious side effects” above for details and possible symptoms of serious skin conditions.

Raised, itchy, white, red, or otherwise discolored bumps that occur after the first few doses of Augmentin may indicate an allergy to the medication. If this occurs, contact your doctor. If you have an allergic reaction, you may need to be treated with a different antibiotic.

Rashes that develop several days after you take the medication and appear as flat, red patches often indicate a different kind of rash that’s not caused by an allergic reaction. These usually go away on their own after a few days.


Fatigue is not a common side effect of Augmentin. However, it’s common for people who are fighting infections to feel fatigued, tired, or weak. If you become fatigued after starting Augmentin, or your symptoms are not improving, talk with your doctor.

Yeast infection

Vaginal yeast infections can sometimes occur after treatment with antibiotics, including Augmentin. If you’ve never had a yeast infection before and think you might have one, see your doctor for a diagnosis and treatment.

Side effects in children

Children who take Augmentin can experience the same side effects as adults.

In addition to those side effects, children can experience tooth discoloration. Augmentin use can cause a brown, gray, or yellow staining of children’s teeth. In most cases, brushing or dental cleaning can reduce or remove the discoloration.

The Augmentin dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you’re using Augmentin to treat
  • your age
  • the form of Augmentin you take
  • other medical conditions you may have
  • body weight, in children

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Forms and strengths

The two forms of Augmentin come in different strengths:

  • oral tablet:
    • 875 milligrams (mg)/125 mg
  • oral liquid suspension (a liquid mixture):
    • 125 mg/31.25 mg per 5 milliliters (mL)
    • 250 mg/62.5 mg per 5 mL
    • 600 mg/42.9 mg per 5 mL

For the strengths listed above, the first number is the amoxicillin amount and the second number is the clavulanic acid amount. The ratio of drug to drug is different for each strength, so one strength can’t be substituted for another.

Dosage for urinary tract infections in adults

  • Typical dosage for severe infections: One 875-mg tablet every 12 hours
  • Treatment length: Usually 10 to 14 days.

Dosage for sinus infection in adults

  • Typical dosage: One 875-mg tablet every 12 hours
  • Treatment length: Usually 5 to 7 days.

Dosage for skin infections such as impetigo in adults

  • Typical dosage: One 875-mg tablet every 12 hours.
  • Treatment length: Usually 7 days.

Dosage for ear infections in adults

  • Typical dosage: One 875-mg tablet every 12 hours.
  • Treatment length: Usually 10 days.

Dosage for respiratory infections such as pneumonia in adults

  • Typical dosage: One 875-mg tablet every 12 hours.
  • Treatment length: Usually 10 days.

Augmentin suspension for adults

The Augmentin liquid suspension form may be used instead of the tablet for adults who have trouble swallowing pills. The suspension comes in different concentrations. Your pharmacist will determine the suspension to use and the amount to take based on your doctor’s prescription.

Pediatric dosage

The liquid suspension form of Augmentin is typically used for children. The dosage depends on the condition being treated, its severity, and the age or weight of the child.

Your pharmacist will determine the concentration of the suspension and the amount your child should take based on their doctor’s prescription.

For infants younger than 3 months old

  • Typical dosage: 30 mg/kg/day (based on the amoxicillin component of Augmentin). This amount is divided and given every 12 hours.
  • Typical form used: The 125-mg/5-mL suspension.

For children 3 months of age and older who weigh less than 88 lb (40 kg)

  • Dosage for less severe infections: 20 mg/kg/day (based on the amoxicillin component of Augmentin), using the 125-mg/5-mL or 250-mg/5-mL suspension. This amount is divided and given every 8 hours.
  • Dosage for more severe infections or ear infections, sinus infections, or respiratory infections: 40 mg/kg/day (based on the amoxicillin component of Augmentin), using the 125-mg/5-mL or 250-mg/5-mL suspension. This amount is divided and given every 8 hours.

For children who weigh 88 lb (40 kg) or more

  • The adult dosage can be used.

What if I miss a dose?

If you miss a dose, take it as soon as you can. However, if it’s just a few hours until your next dose, skip the missed dose and take the next one on schedule.

Never try to catch up by taking two doses at a time. This can cause dangerous side effects.

Augmentin is available in a generic form. The generic name of Augmentin is amoxicillin/clavulanate potassium.

Generic drugs are often less expensive than the brand-name version. In some cases, the brand-name drug and the generic version may be available in different forms and strengths.

As with all medications, the cost of Augmentin can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Before approving coverage for Augmentin, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide whether the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Augmentin, contact your insurance company.

Savings for Augmentin

Visit this page to access Optum Perks coupons and get price estimates for Augmentin when you use the coupons. These coupons can provide significant savings on your prescription costs.

Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

Financial and insurance assistance

If you need financial support to pay for Augmentin, or if you need help understanding your insurance coverage, help is available.

Medicine Assistance Tool and NeedyMeds are two websites offering resources that may help decrease the price you pay for Augmentin. They also offer tools to help you find low cost healthcare, as well as educational resources. To learn more, visit their sites.

To learn more about saving money on prescriptions, check out this article.

Mail-order pharmacies

Augmentin may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home. You can also ask your doctor or pharmacist about online pharmacy options.

Generic version

Augmentin is available in a generic form called amoxicillin/clavulanate potassium. A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be as safe and effective as the original drug. And generics tend to cost less than brand-name drugs. To find out how the cost of amoxicillin/clavulanate potassium compares to the cost of Augmentin, talk with your doctor or pharmacist.

If your doctor has prescribed Augmentin and you’re interested in using generic amoxicillin/clavulanate potassium instead, talk with your doctor. They may have a preference for one version or the other. You’ll also need to check your insurance plan, as it may only cover one or the other.

Augmentin is commonly used in adults and children to treat infections of the urinary tract, respiratory tract, ear, sinuses, and skin. Some of these uses are approved by the Food and Drug Administration (FDA) and some are off-label. Off-label drug use refers to prescribing a drug for a purpose other than what it’s been approved for by the FDA.

The following information describes some of the common uses of Augmentin.

Augmentin for urinary tract infection (UTI)

Augmentin is FDA-approved for treating UTIs. According to the Infectious Diseases Society of America, Augmentin is not a first-choice antibiotic for UTI. It should be used when other medications such as trimethoprim-sulfamethoxazole cannot be used.

Augmentin for sinus infection / sinusitis

Augmentin is FDA-approved for treating sinus infections in adults and children. Augmentin is considered a first-choice medication for this condition.

Augmentin for strep

Augmentin is not FDA-approved for treating strep throat, which is also known as streptococcus pharyngitis. In addition, the Infectious Diseases Society of America does not recommend Augmentin for treating most cases of strep throat.

Augmentin for pneumonia

Augmentin is FDA-approved for treating pneumonia. They’re typically not first-choice antibiotics for pneumonia. However, they’re often used in people with pneumonia who also have other medical conditions such as diabetes, liver or kidney disease, or heart disease.

When used to treat pneumonia, Augmentin is typically used in combination with other antibiotics.

Augmentin for ear infection

Augmentin is FDA-approved to treat ear infections, also known as otitis media, in children and adults.

However, according to the American Academy of Pediatrics, Augmentin is not usually the first-choice antibiotic for treating ear infections in children.

Augmentin is often reserved for children who have recently been treated with another antibiotic such as amoxicillin. It may also be reserved for those who have had previous ear infections that were not effectively treated by amoxicillin.

Augmentin for cellulitis

Cellulitis is a type of skin infection. Augmentin is FDA-approved to treat some types of skin infections, including cellulitis caused by certain bacteria. However, Augmentin is usually not the first-choice antibiotic for treating cellulitis.

Augmentin for bronchitis

Augmentin is approved to treat certain types of respiratory infections. In some cases, this can include bronchitis.

Bronchitis is often caused by a virus, so antibiotics are not usually effective in treating it. But if you have a cough that doesn’t go away and your doctor suspects it’s caused by a bacterial infection, they may consider treating you with antibiotics such as Augmentin.

Augmentin for acne

Antibiotics are sometimes used for treating certain types of acne. Although it may be used off-label for treating acne, Augmentin is not usually a first choice for this purpose.

Augmentin for diverticulitis

Augmentin is not FDA-approved for treating diverticulitis. However, it’s used off-label to treat it.

Drinking alcohol while taking Augmentin may increase your risk of certain side effects, or make your side effects worse.

Examples of side effects that might be more likely to occur or worsen with alcohol use include:

  • vomiting
  • dizziness
  • upset stomach
  • liver problems

If you drink alcohol, ask your doctor how much alcohol (if any) is safe for you to consume while you take Augmentin.

Augmentin can interact with several other medications. It can also interact with certain foods.

Augmentin and other medications

Below is a list of medications that can interact with Augmentin. This list does not contain all drugs that may interact with Augmentin.

Different drug interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Before taking Augmentin, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Anticoagulant drugs

Taking Augmentin with oral anticoagulant drugs (blood thinners taken by mouth) such as warfarin (Jantoven) might increase the effects of the anticoagulants. This could result in increased bleeding.

If you take an anticoagulant drug with Augmentin, your doctor may need to monitor your bleeding risk more often.


Taking Augmentin with allopurinol (Zyloprim, Aloprim) might increase your risk of developing a skin rash.

Oral contraceptives

Some antibiotics, including Augmentin, might decrease how well oral contraceptives (birth control taken by mouth, such as the birth control pill) work. However, research on this interaction is inconsistent and controversial.

Until more is known about this potential interaction, consider using a backup method of contraception while taking Augmentin.

Augmentin and Tylenol

There is no known interaction between Augmentin and Tylenol (acetaminophen).

Augmentin and dairy

Milk and other dairy foods can interact with some antibiotics. However, they don’t interact with Augmentin.

In addition to the information above, you can also refer to this article for details about Augmentin’s interactions.

Take Augmentin exactly according to your doctor’s instructions. You might start to feel better before you finish your entire treatment. But even if you do feel better, do not stop taking Augmentin. In many cases, it’s important to finish the entire treatment to ensure that the infection does not come back.

If you’re feeling better and want to stop Augmentin early, be sure to ask your doctor if it’s safe to do so.


Augmentin is taken two or three times daily. If you take it twice daily, spread out the doses so that they’re about 12 hours apart. If you take it three times daily, spread out the doses so that they’re about eight hours apart.

Taking Augmentin with food

You should take Augmentin with a meal. Taking it with a meal may reduce stomach upset and help your body absorb the drug better.

Can Augmentin be crushed?

Augmentin oral tablets can be crushed. If the tablet is scored (has an indented line across it), it can be split in half.

If you have trouble swallowing pills, ask your doctor or pharmacist about taking Augmentin liquid suspension instead.

Augmentin is a penicillin-type antibiotic. It contains two components: amoxicillin and clavulanic acid. The clavulanic acid ingredient makes Augmentin effective against bacteria that amoxicillin or other penicillin drugs may not work against when they’re taken by themselves.

Augmentin kills bacteria by attaching to proteins within the bacteria cell. This prevents the bacteria from building a cell wall, which results in the death of the bacteria.

Augmentin is considered a broad-spectrum antibiotic. This means it works against many different types of bacteria.

How long does it take to work?

Augmentin begins to work against bacterial infections within hours of when you take it. However, you may not notice improvement in your symptoms for a few days.

Augmentin’s use during pregnancy has not been studied enough to know for sure what effects it could have. Animal studies have not found any harm to the fetus when Augmentin was given to pregnant animals. However, animal studies don’t always predict what would happen in humans.

Augmentin should only be used during pregnancy if there’s a clear need for its use.

Augmentin is known to pass into breast milk in small amounts. Although it’s generally considered safe to use during breastfeeding, it may lead to side effects in a child who is breastfed.

If you’re breastfeeding your child, talk with your doctor before taking Augmentin. They can help determine whether the benefits of Augmentin treatment while breastfeeding outweigh the risks.

Augmentin and amoxicillin may be easily confused with each other, but they’re not the same drug.

Is Augmentin amoxicillin?

No, they’re different medications. Augmentin is a combination medication that contains amoxicillin in addition to another drug.

The other ingredient, which is called clavulanic acid, helps the amoxicillin in Augmentin work against bacteria that are normally resistant to amoxicillin when it’s used alone. (Resistant bacteria don’t respond to treatment with a certain antibiotic.)

Augmentin and amoxicillin are often used to treat similar types of infections. If your doctor thinks that your infection may be resistant to amoxicillin alone, they may recommend Augmentin instead.

Is amoxicillin or Augmentin stronger?

Because it contains amoxicillin as well as clavulanic acid, Augmentin works against more types of bacteria than amoxicillin alone. In this regard, it could be considered stronger than amoxicillin.

For more information about how Augmentin and amoxicillin compare, you can refer to this article.

Here are answers to some frequently asked questions about Augmentin.

Is Augmentin a type of penicillin?

Yes, Augmentin is an antibiotic in the class of penicillins. It’s called a broad-spectrum penicillin. This is because it works against many different types of bacteria, including some that are normally resistant to penicillin drugs.

How long does Augmentin take to work?

Augmentin starts working within a few hours of when you take it. However, your symptoms may not start to improve for a few days after that.

Can Augmentin make you tired?

Augmentin doesn’t typically make you feel tired or drowsy. But if your body is fighting an infection, you’re more likely to feel weak or tired.

If you’re concerned about how tired you feel while you take Augmentin, talk with your doctor.

If I get diarrhea when I take Augmentin, does that mean I’m allergic to it?

Diarrhea and upset stomach are common side effects of Augmentin. If you experience them, it doesn’t necessarily mean you have an allergy to the medication.

However, if you have severe diarrhea or diarrhea that doesn’t go away, you should talk with your doctor.

Can Augmentin be used in cats or dogs?

Veterinarians sometimes prescribe Augmentin to treat infections in dogs and cats. The form approved for animals is called Clavamox. It’s commonly used for skin infections and gum disease in animals, but may also be used for other kinds of infections.

If you think your dog or cat has an infection, see your veterinarian for an evaluation and treatment. Different doses of this drug are used for animals than for humans, so don’t try to treat your pet with a human prescription of Augmentin.

If your dog or cat eats your prescription Augmentin, call your vet right away.

There are other antibiotics that are often used to treat the same conditions as Augmentin. Some may be better suited for you than others.

The best choice of antibiotic may depend on your age, the type and severity of your infection, previous treatments you’ve used, and patterns of bacterial resistance in your area.

To learn more about other medications that may work well for you, talk with your doctor.

Alternatives for UTI

Examples of other drugs that may be used to treat urinary tract infections (UTIs) include:

  • nitrofurantoin (Macrobid, Macrodantin)
  • trimethoprim-sulfamethoxazole (Bactrim, Sulfatrim)
  • ciprofloxacin (Cipro)
  • levofloxacin

Alternatives for sinus infections

Examples of other drugs that may be used to treat sinus infections include:

  • amoxicillin
  • doxycycline (Acticlate, Doryx, Doryx MPC, Vibramycin)
  • levofloxacin
  • moxifloxacin

Alternatives for skin infections

Examples of other drugs that may be used to treat skin infections include:

Alternatives for ear infections

Examples of other drugs that may be used to treat ear infections include:

  • amoxicillin
  • cefdinir
  • cefuroxime
  • cefpodoxime
  • ceftriaxone

Alternatives for pneumonia

Examples of other drugs that may be used to treat pneumonia include:

  • azithromycin (Zithromax)
  • clarithromycin
  • erythromycin (Ery-Tab)
  • doxycycline (Acticlate, Doryx, Doryx MPC)
  • levofloxacin
  • moxifloxacin
  • amoxicillin
  • ceftriaxone
  • cefpodoxime
  • cefuroxime

Taking too much of this medication can increase your risk of severe side effects.

Overdose symptoms

Symptoms of an overdose of Augmentin can include:

  • nausea
  • vomiting
  • abdominal pain
  • dizziness
  • kidney damage or failure

What to do in case of overdose

If you think you or your child has taken too much of this drug, call your doctor or seek guidance from America’s Poison Centers at 800-222-1222 or through its online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Overdose treatment

Treatment of overdose will depend on the symptoms you have. A doctor may do tests to check for problems with your heart, liver, or kidneys, or breathing issues. They may also check your oxygen levels. In some cases, they may administer intravenous (IV) fluids.

When Augmentin is dispensed from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date the medication was dispensed.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, ask your pharmacist how to properly dispose of it.


How long a medication remains good can depend on many factors, including how and where the medication is stored.

Augmentin pills should be stored at room temperature in a tightly sealed and light-resistant container. The dry powder for the liquid suspension should also be stored at room temperature. The mixed liquid suspension should be refrigerated. It’s good for 10 days in the refrigerator.


If you no longer need to take Augmentin and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Before taking Augmentin, talk with your doctor about any medical conditions you have. Augmentin may not be a good choice for you if you have certain medical conditions.

These conditions include:

  • Allergies to antibiotics. If you’ve had an allergic reaction to penicillin antibiotics or cephalosporin antibiotics, you’re more likely to have an allergic reaction to Augmentin. If you’ve had an allergic reaction to any antibiotic in the past, be sure to tell your doctor before you take Augmentin.
  • Liver disease. It’s not common, but some people who take Augmentin can develop liver damage. This seems to be more common in those who take Augmentin for a long period of time. If you already have liver disease, your doctor may decide that you should not take Augmentin. Or, they may do blood tests to check your liver function while you take Augmentin.
  • Mononucleosis. Many people who have mononucleosis develop a skin rash after taking Augmentin. If you have mononucleosis, you should not take Augmentin.
  • Kidney disease. If you have severe kidney disease, your doctor may prescribe Augmentin at a lower dosage than usual. Be sure to discuss your health history with your doctor.
  • Pregnancy. Augmentin’s use during pregnancy has not been studied enough to know what effects it could have. This drug should only be used during pregnancy if there’s a clear need for its use. For more information, see the “Augmentin and pregnancy” section above.
  • Breastfeeding. Augmentin is often considered safe to use during breastfeeding, but may cause side effects in a child who’s breastfed. For more information, see the “Augmentin and breastfeeding” section above.

The following information is provided for clinicians and other healthcare professionals.

Mechanism of action

Augmentin contains amoxicillin and clavulanic acid. Amoxicillin is a beta-lactam antibiotic that has bactericidal activity against Gram-negative and Gram-positive bacteria.

Beta-lactamase-producing bacteria are resistant to amoxicillin. Clavulanic acid is also a beta-lactam that can inactivate some forms of beta-lactamase.

The combination of amoxicillin and clavulanic acid extends the spectrum of Augmentin against bacteria that are normally resistant to amoxicillin alone.

Pharmacokinetics and metabolism

The oral bioavailability of the amoxicillin component of Augmentin is about 74 percent to 92 percent. The peak blood level of amoxicillin and clavulanic acid occurs between one and two-and-a-half hours after oral intake.

The half-life of the amoxicillin component is about 1 hour and 20 minutes, and about 1 hour for clavulanic acid.


Augmentin is contraindicated in people with a history of serious hypersensitivity reactions to amoxicillin, clavulanic acid, penicillin, or cephalosporin antibiotics.

It’s also contraindicated in people with a history of cholestatic jaundice or liver dysfunction following treatment with Augmentin.


Augmentin tablets or powder should be stored in the original container at temperatures of 77 degrees F (25 degrees C) or less. Reconstituted Augmentin suspensions should be stored in a refrigerator and discarded after 10 days.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.