The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active ingredient (in each tablet)Acetaminophen 325 mg
Otc - Purpose
PurposePain reliever/ Fever reducer
- Temporarily reduces fever and relieves minor aches and pains due to:headache muscular aches backache minor pain of arthritiscommon cold toothache premenstrual and menstrual cramps
- Liver warning: 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
- Adult takes more than 4,000 mg of acetaminophen in 24 hourschild takes more than 5 doses in 24 hours, which is the maximum daily amounttaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks every day while using this productAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddening blistersrashIf a skin reaction occurs, stop use and seek medical help right away.
Do Not Use
- 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
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - Stop Use
- Stop use and ask a doctor if
- Pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children under 12 yearsfever gets worse or lasts more than 3 daysnew symptoms occur redness or swelling is presentThese could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
This Unit Dose package is not childresistant and is Intended for Institutional Use Only.
- Do not take more than directed (see overdose warning)adults and children 12 years and over:take 2 tablets every 4 to 6 hours while symptoms lastdo not take more than 10 tablets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctorchildren 6 years to under 12 yearstake 1 tablet every 4 to 6 hours while symptoms lastdo not take more than 5 tablets in 24 hoursdo not use for more than 5 days unless directed by a doctorchildren under 12 years: ask a doctor
Store at room temperature
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.
Tamper Evident: Do not use if sealed blister units are broken or damaged.
MAJOR® PHARMACEUTICALS17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152
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