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Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Cardinal Health
NDC Code: 55154-5552
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
500 mg Caplets
Pain Reliever/Fever Reducer
Contains No Aspirin
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Keep out of reach of children.
temporarily relieves minor aches and pains due to:
- muscular aches
- minor pain of arthritis
- the common cold
- premenstrual and menstrual cramps
- temporarily reduces fever
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.
Do not use with any other product containing acetaminophen
Stop use and ask a doctor if
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Overdose Warning: Taking more than the recommended dose
(overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than directed (see overdose warning)
- Adults and children 12 years of age and over
- take 2 caplets every 4 to 6 hours while symptoms last
- do not take more than 8 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
- Children under 12 years
- do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
pregelatinized starch, povidone, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, carnauba wax
Acetaminophen Extra Strength Caplets are available as follows:
500 mg - White to off-white, capsule shaped, film coated caplets with 112 debossed on one side.
NDC 51079-396-20 - Unit dose blister packages of 100 (10 cards of 10 caplets each).
NDC 51079-396-19 - Robot Ready blister packages of 25 (25 cards of 1 caplet each).
Store between 20-25°C (68-77°F)
- do not use if blister units are torn, broken or show any signs of tampering
Serious side effects associated with use of this product may be reported to this number.
Amneal Pharmaceuticals Corp.
Paterson, NJ 07504
Packaged and Distributed by:
UDL Laboratories, Inc.
Rockford, IL 61103
|Labeler - Cardinal Health (188557102)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.