Drug Facts
Composition & Profile
Identifiers & Packaging
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC: 17714-133-50 – 50 COUNT CAPLETS 079fcfcb-figure-01 079fcfcb-figure-02
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC: 17714-133-50 – 50 COUNT CAPLETS 079fcfcb-figure-01 079fcfcb-figure-02
Overview
Uses temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Indications & Usage
Uses temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Dosage & Administration
Directions do not take more than directed adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years : do not use this adult product in children under 12 years of age; this will provide more than the recommended dose(overdose) and may cause liver damage
Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. 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. with any other drug containing diphenhydramine, even one used on skin in children under 12 years of age Ask a doctor before use if the you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedative or tranquilizers when using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks, insomnia may be a symptom of serious underlying medical illness. Any new symptoms appear redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days If pregnant or breast-feeding, ask a health professional before use.
Purpose
Purpose Pain Reliever / Night time sleep aid
Keep Out of Reach of Children
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.
Questions
Questions or Comments Call 631-981-4600 8.30 am- 4.30 pm ET, Monday-Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742
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