Allergy Relief Diphenhydramine Hcl 25mg Softgel Capsule, Liquid Filled
FDA Label NDC 72090-052

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Allergy Relief Diphenhydramine Hcl 25mg Softgel (NDC 72090-052). 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 (in each softgel), purpose, uses, warnings, ask a doctor before use if you have, directions:, other information:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 25mg

Purpose

Antihistamine

Uses

■temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■runny nose ■sneezing ■itchy, watery eyes ■itching of the 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 skin.

Ask A Doctor Before Use If You Have

■ glaucoma
■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis.

Directions:

■ Take every 4 to 6 hours, or as directed by a doctor
■ Do not take more than 6 doses in 24 hours.
■ Adults and children 12 years and over: 1 to 2 softgels
■ Children 6 years to under 12 years: 1 softgel
■ Children under 6 years: Do not use

Other Information:

■ Store between 20°-25°C (68°-77°F). Avoid high humidity. Protect from moisture and light.

Inactive Ingredients:

Polyethylene Glycol 400, Propylene Glycol, Gelatin, Glycerin, Sorbitol Sorbitan Solution, Purified Water

* Please review the disclaimer below.