Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - Carton Label REGULAR STRENGTH Pain Relief Acetaminophen 325 mg 20 SOFTGELS NDC 27854-388-01 * Compare to the active ingredient in TYLENOL ® Regular Strength Carton Label Front Carton Label Back-01 Carton Label Back-02; PRINCIPAL DISPLAY PANEL - Bottle Label REGULAR STRENGTH Pain Relief Acetaminophen 325 mg 20 SOFTGELS NDC 27854-388-01 Bottle Label Front Bottle Label Back
- PRINCIPAL DISPLAY PANEL - Carton Label REGULAR STRENGTH Pain Relief Acetaminophen 325 mg 20 SOFTGELS NDC 27854-388-01 * Compare to the active ingredient in TYLENOL ® Regular Strength Carton Label Front Carton Label Back-01 Carton Label Back-02
- PRINCIPAL DISPLAY PANEL - Bottle Label REGULAR STRENGTH Pain Relief Acetaminophen 325 mg 20 SOFTGELS NDC 27854-388-01 Bottle Label Front Bottle Label Back
Overview
Uses temporarily relieves 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
Indications & Usage
Uses temporarily relieves 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
Dosage & Administration
Directions do not take more than directed ( see Overdose warning) adults and children 12 years and over take 2 softgels every 4 to 6 hours while symptoms last do not take more than 10 softgels in 24 hours do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years take 1 softgel every 4 to 6 hours while symptoms last do not take more than 5 softgels in 24 hours do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor
Warnings & Precautions
Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (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 hours child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If 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 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 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 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.
Purpose
Purpose Pain reliever/fever reducer
Do Not Use
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
Stop Use & Ask a Doctor
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 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.
Keep Out of Reach of Children
Keep out of reach of children.
Storage & Handling
Other information store at 15°-30°C (59°-86°F) and avoid excessive heat.
Questions
Questions or comments? Call toll free: 1-888-779-2877 Monday to Friday 9AM - 5PM EST
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