409 - Allergy Dye Free

SPL v2

SPL

SPL Set ID 15736bb8-5a5b-489d-83ad-4cf34ec62956

Route

ORAL

Published

Effective Date 2021-04-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Gelatin Glycerin Polyethylene Glycol, Unspecified Water Sorbitol Solution

Identifiers & Packaging

Pill Appearance

Imprint: PC4 Shape: capsule Color: yellow Size: 15 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-09-15

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Use(s)

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

Storage

store between 20-25 °C (68-77 °F).
Avoid high humidity and excessive heat. Protect from light.

Questions

Call 1-888-952-0050

Monday through Friday 9AM - 5PM EST

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

Adults and children 12 years and over: 1 to 2 softgels

Children 6 to under 12 years: 1 softgel

Children under 6 years: do not use this product in children under 6 years of age

Do Not Use

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

Other Information

do not use if blister is torn or broken

Active Ingredient(s)

Diphenhydramine HCl 25 mg

Inactive Ingredients

gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Diphenhydramine HCL 25mg

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

Ask A Doctor Before Use If

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

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If

taking sedatives or tranquilizers

Structured Label Content

Use(s)

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

Purpose

Antihistamine

Storage

store between 20-25 °C (68-77 °F).
Avoid high humidity and excessive heat. Protect from light.

Questions

Call 1-888-952-0050

Monday through Friday 9AM - 5PM EST

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

Adults and children 12 years and over: 1 to 2 softgels

Children 6 to under 12 years: 1 softgel

Children under 6 years: do not use this product in 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 (Other information)

do not use if blister is torn or broken

Active Ingredient(s) (Active ingredient(s))

Diphenhydramine HCl 25 mg

Inactive Ingredients (Inactive ingredients)

gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

Diphenhydramine HCL 25mg

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

Ask A Doctor Before Use If (Ask a doctor before use if)

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

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 (1-800-222-1222) right away.

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

taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL SOLUTION", "unii": "8KW3E207O2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "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", "Purpose": "Antihistamine", "Storage": "store between 20-25 °C (68-77 °F). Avoid high humidity and excessive heat. Protect from light. ", "Questions": "Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST", "Directions": "take every 4 to 6 hours do not take more than 6 doses in 24 hours Adults and children 12 years and over: 1 to 2 softgels Children 6 to under 12 years: 1 softgel Children under 6 years: do not use this product in children under 6 years of age", "Do not use": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Other information": "do not use if blister is torn or broken", "Active ingredient(s)": "Diphenhydramine HCl 25 mg", "Inactive ingredients": "gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink", "Pregnancy/Breastfeeding": "ask a health professional before use.", "Principal Display Panel": "Diphenhydramine HCL 25mg", "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", "Ask a doctor before use if": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "Ask a doctor or pharmacist before use if": "taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:20.758859 · Updated: 2026-03-14T23:01:49.492831