The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Cardinal Health
NDC Code: 55154-5837
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.
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Keep this and all drugs out of the reach of children.
Temporarily relieves minor aches and pains due to headache, backache, toothache, flu, minor pain of arthritis, muscular aches, pre-menstrual and menstrual cramps, the common cold and temporarily reduces fever.
This package is intended for institutional use only.
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
Do not use with any other product containing acetaminophen.
Stop use and ask a doctor if new symptoms occur, redness or swelling is present, pain gets worse or lasts for more than 10 days or fever gets worse or last more than 3 days. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
TAMPER-EVIDENT: Each tablet is individually sealed. Do not use if blister is torn or broken.
This unit dose package is not child-resistant. If dispensed for outpatient use, a child resistant container should be utilized.
do not take more than directed (see overdose warning)
- adults and children 12 years and over: take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by doctor.
- children under 12 years: Do not use this adult extra strength product in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
povidone, starch, stearic acid
Store at Room Temperature 15-30 C (59-86 F)
call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time
Goldline Laboratories, INC.
a subsidiary of IVAX Pharmaceuticals, Inc.
Miami, FL 33137-3227
by: LNK International, Inc.
Hauppauge, NY 11788
Repackaged by Cardinal Health
Zanesville, OH 43701
|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.