ACETAMINOPHEN by FREDS, INC
Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: FREDS, INC
NDC Code: 55315-101
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
- for the temporary relief of minor aches and pains due to:
- muscular aches
- minor pain of arthritis
- the common cold
- premenstrual and menstrual cramps
- temporarily reduces fever
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
taking the blood thinning drug warfarin.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts 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 the 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 and over:
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours unless directed by a doctor
- do not take more than 10 days unless directed by a doctor
Children under 12 years: ask a doctor
- Store at room temperature
Hypromellose,Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.
If you have any questions or comments, or to report an adverse event, please contact (888) 876-6898.
|Labeler - FREDS, INC (005866116)|
|Gemini Pharmaceuticals, Inc.||055942270||manufacture(55315-101)|
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.