Free And Pure Allergy Relief Dye-free

SPL v4

SPL

SPL Set ID 93182db8-05bc-4eb5-aa14-cef58de25359

Route

ORAL

Published

Effective Date 2023-10-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Glycerin Gelatin Polyethylene Glycol 400 Povidone Water Sorbitol Sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: SD12 Shape: capsule Color: white Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-10-22

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Uses

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

Section 42229-5

Distributed By:

Walgreen Co.

200 Wilmot Rd., Deerfield, IL 60015

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours
adults and children 12 years of age and over - take 1 to 2 softgels
children 6 to under 12 years of age - take 1 softgel
children under 6 years of age - do not use

Do Not Use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Other Information

store between 20-25ºC (68 to 77°F). Avoid high humidityandexcessive heat.
Protect from light, heat, humidity

Inactive Ingredients

gelatin, glycerin, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments?

1-800-373-6981

Principal Display Panel

Free & Pure Dye-Free

Allergy Relief

Diphenhydramine HCl 25 mg/Antihistamine

Relieves:

Sneezing

Itchy throat

Runny nose

Itchy, watery eyes

When Using This Product

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

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)

If Pregnant or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Distributed By:

Walgreen Co.

200 Wilmot Rd., Deerfield, IL 60015

Purpose

Antihistamine

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours
adults and children 12 years of age and over - take 1 to 2 softgels
children 6 to under 12 years of age - take 1 softgel
children under 6 years of age - do not use

Do Not Use (Do not use)

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Other Information (Other information)

store between 20-25ºC (68 to 77°F). Avoid high humidityandexcessive heat.
Protect from light, heat, humidity

Inactive Ingredients (Inactive ingredients)

gelatin, glycerin, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

1-800-373-6981

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Free & Pure Dye-Free

Allergy Relief

Diphenhydramine HCl 25 mg/Antihistamine

Relieves:

Sneezing

Itchy throat

Runny nose

Itchy, watery eyes

When Using This Product (When using this product)

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Keep Out of Reach of Children. (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)

If Pregnant or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing, runny nose, itchy, watery eyes, itching of the nose or throat temporarily relieves these symptoms due to common cold: runny nose, sneezing ", "42229-5": "Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015", "Purpose": "Antihistamine", "Directions": "take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years of age and over - take 1 to 2 softgels children 6 to under 12 years of age - take 1 softgel children under 6 years of age - do not use", "Do not use": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Other information": "store between 20-25ºC (68 to 77°F). Avoid high humidityandexcessive heat. Protect from light, heat, humidity", "Inactive ingredients": "gelatin, glycerin, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution", "Questions or comments?": "1-800-373-6981", "PRINCIPAL DISPLAY PANEL": "Free & Pure Dye-Free Allergy Relief Diphenhydramine HCl 25 mg/Antihistamine Relieves: Sneezing Itchy throat Runny nose Itchy, watery eyes", "When using this product": "marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "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)", "If pregnant or breast-feeding,": "ask a health professional before use.", "Active ingredient (in each softgel)": "Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:39.331138 · Updated: 2026-03-14T23:13:21.652895