Aphenap
FDA Label NDC 46084-041

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A P J Laboratories Limited for the product Aphenap (NDC 46084-041). 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 active ingredient, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Purpose

Antihistamine

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).

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose

Warnings

Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

Directions

Adults and children 12 years and over: take 25 to 50 mg (1 to 2 tablet) every 4 to 6 hours; not more than 12 tablets in 24 hours.

Children 6 years to 12 years of age: take 25 mg (1 tablet) every 4 to 6 hours; not more than 6 tablets in 24 hours.

Children under 6 years of age: ask a doctor

Inactive Ingredient

CELLULOSE, MICROCRYSTALLINE

MAGNESIUM STEARATE


METHYLPARABEN

POVIDONE K30

SILICON DIOXIDE

SODIUM STARCH GLYCOLATE TYPE A POTATO

STARCH, CORN

TALC

TITANIUM DIOXIDE

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