acetaminophen tablet Drug Facts
Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals
Active ingredient (in each caplet)
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
Do not use
- with any other drug containing acetaminophen (prescription or non prescription). 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.
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
Stop use and ask a doctor if
- 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.
Keep out of reach of children.
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 for more than 10 days unless directed by a doctor
Children under 12 years: ask a doctor
Do not use if imprinted safety seal under cap is broken or missing.
- Store at room temperature
Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.
If you have any questions or comments, or to report an adverse event, please contact 1 800-medline.
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Acetaminophen 500 mg
CONTAINS NO ASPIRIN
Compare to the Active ingredient in Extra Strength Tylenol®
This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®
1000 CAPLETS 500 mg each
|HUMAN OTC DRUG
|NDC Product Code (Source)
|Route of Administration
|Active Ingredient/Active Moiety
|Basis of Strength
|SODIUM STARCH GLYCOLATE TYPE A POTATO
|OVAL (Capsule shaped tablet)
|Application Number or Monograph Citation
|Marketing Start Date
|Marketing End Date
|OTC monograph final
|Labeler - Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals
Registrant - Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals (055942270)
Revised: 04/2012Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals
|Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals