ACETAMINOPHEN by SPIRIT PHARMACEUTICALS LLC
Medically reviewed on May 15, 2017
Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: SPIRIT PHARMACEUTICALS LLC
NDC Code: 68210-0022
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 325 mg
Pain reliever/fever reducer
- temporarily relieves minor aches and pains due to:
- the common cold
- minor pain of arthritis
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. 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 drugs every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
- 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.
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
- pain gets worse or lasts more than 10 days in adults
- 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.
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 and over||
|children 6 years to under 12 years||
|children under 6 years||ask a doctor|
- store between 20-25°C (68-77°F)
- do not use if carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL" is broken or missing
povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
|Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)|
|TIME-CAP LABS INC||037052099||manufacture(68210-0022)|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.