Allergy Relief Tablet, Film Coated
FDA Label NDC 49483-061

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories, Inc for the product Allergy Relief (NDC 49483-061). 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS:

In each tablet : DIPHENHYDRAMINE HCL

 

Otc - Purpose

PURPOSE:  ANTIHISTAMINE

Otc - Keep Out Of Reach Of Children

Keep Out of the Reach of Children:   In case of overdose, get medical help or contact a Poison Control Center right away

Indications & Usage

INDICATIONS AND USAGE:

TEMPORARILY RELIEFSTHESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES:

RUNNING NOSE, ITCHY, WATERY EYES, SNEEZING, ITCHY NOSE OR THROAT

TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO THE COMMON COLD:  RUNNY NOSE, SNEEZING

Warnings

Do not use to make a child sleepy; with any other product containing diphenhydramine, even one used on skik

Dosage & Administration

Directions - take every 4 t0 6 hours.
Do not take more than 6 doses in 24 hours.
adults and children 12 years of age and older - 1 to 2 caplets
children 6 to under 12 years of age - 1 caplet
children under 6 years of age - do not use this product in children under 6 years of age






Inactive Ingredient

carnauba wax, colloidal silicon dioxide, d-c red no 27 aluminum lke, dibasic calcium phosphate dehydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-PEG-400, polysorbate80, titanium dioxide.

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