ACETAMINOPHEN
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acetaminophen tablet
Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals
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.
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Active Ingredients
Acetaminophen 325 mg
Purposes
Pain reliever/fever reducer
Uses
for the temporary relief of minor aches and pains due to:
- Headache
- Muscular aches
- Backache
- Minor pain of arthritis
- The common cold
- Toothache
- Premenstrual and menstrual cramps
Temporarily reduces fever.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 12 tablets in 24 hours,which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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 the user has
liver disease
Ask a doctor or pharmacist before use if the user is
taking the blood thinning drug warfarin
Stop use and ask a doctor if
- Pain gets worse or lasts more than 10 days in adults and children
- Pain gets worse or lasts more than 5 days in children under 12 years
- 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 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.
Directions
Do not take more than directed
AGE | DOSE |
Adults and children 12 years and over |
- Take 2 tablets every 4 to 6 hours while symptoms last
- Do not take more than 12 tablets in 24 hours
|
Children 6 to 11 years |
- Take 1 tablet every 4 to 6 hours while symptoms last
- Do not take more than 5 tablets in 24 hours
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Children under 6 years | Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
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Other information
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Do not use if imprinted safety seal under cap is broken or missing.
- Store at room temperature
Inactive Ingredients
Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid
Questions?
If you have any questions or comments or to report an adverse event, please contact 1-800-medline.
Principal Display Panel 325 mg
ONDRA Pharmaceuticals
See new warning information and directions
Regular Strength
Acetaminophen 325 mg
PAIN RELIEVER
FEVER REDUCER
CONTAINS NO ASPIRIN
Compare to active ingredient in Regular strength Tylenol®
1000 tablets
325mg each
ONDRA Pharmaceuticals
See new warning information and directions
Regular Strength
Acetaminophen 325 mg
PAIN RELIEVER
FEVER REDUCER
CONTAINS NO ASPIRIN
Compare to active ingredient in Regular strength Tylenol®
100 tablets
325mg each
ACETAMINOPHEN
acetaminophen tablet |
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Revised: 04/2012 Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals