Powerful Pain Medicine
FDA Label NDC 10956-762

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Reese Pharmaceutical Co. for the product Powerful Pain Medicine (NDC 10956-762). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Acetaminophen;     650 mg

Otc - Purpose

Acetaminophen 650 mg ;  pain reliever ; fever reducer

Otc - Keep Out Of Reach Of Children

keep out of reach of children.

Indications & Usage

temporarily relieves minor aches and pains due to

common cold ; headaches ; toothaches ; muscular aches ;

backache ; minor arthritis pain ; menstrual cramps ; temporarily reduces fevers

Warnings

LIVER  WARNING This product contains  acetaminophen.severe liver damage may occur if adult takes more than 6 doses in 24 hourswhich is the maximum daily amount.child takes more than 5 doses in 24 hourswhich is the maximum daily amount.taken with other drugs containing acetaminophen.adult has 3 or more alcoholic drinks everyday while using this product.

Dosage & Administration

Directions

do not use more than directed

adults and children 12 years of age and older take 1 caplet

every 4 hours as needed.

do not exceed 6 doses in a 24 hour period or as directed by a doctor.

children under 12 years of age;

do not use this adult product in children under 12 years of age

this will provide more than the recommended dose ( overdose ) of

non aspirin and could cause health problems.

Inactive Ingredient

polyvinylpyrrolidone ; pregelaatinized starch ; sodium starch glycolate ;

stearic acid.

Package Label.Principal Display Panel

Image Of Carton (Reesepainezea65v1)

Image Of Carton (Reesepainezea65v1)

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