A+ Health-diphenhydramine Hydrochloride Capsules, 25 Mg-dye Free

SPL v2

SPL

SPL Set ID 323347c3-d51a-4976-e063-6294a90a952e

Route

ORAL

Published

Effective Date 2025-04-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Sorbitan Gelatin Polyethylene Glycol 400 Water Glycerin Propylene Glycol Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: DF25 Shape: capsule Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-12-11

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 the other upper respiratory allergies:

■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes

Section 42229-5

THIS PRODUCT IS PACKAGED IN A TAMPER EVIDENT PACKAGE.

USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by the owners of Benadryl® Allergy LIQUI-GELS®

Manufactured for:

BIONPHARMA

Princeton, NJ 08540

MADE IN INDIA

Mfg. Lic. No.: TN00002123

2122718

L0000935

R1124

Warnings

■ May cause excitability especially in children.

■ May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

48's Count

NDC 69452-453-09

†Compare to the active ingredient in Benadryl ^®Allergy LIQUI-GELS ^®†

a+ health

dye-free

allergy refief

diphenhydramine HCl capsules

USP, 25 mg

antihistamine

48 softgels**

**liquid-filled capsules

• sneezing • runny nose

• itchy, watery eyes • itchy throat or nose

Directions

■ Do not use for children under 6 years of age ■ do not take more than 6 doses in 24 hours

adults and children 12 years and over	1 to 2 capsules
children 6 to under 12 years	1 capsule
children under 6 years	do not use this product for children under 6 years of age

Do Not Use

■ Do not use for children under 6 years of age ■ with any other product containing diphenhydramine, even one used on skin.

Other Information

■ store at 20°C to 25°C (68°F to 77°F)

■ avoid high humidity and excessive heat above 40°C (104°F).

■ protect from light

Inactive Ingredients

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

Questions Or Comments?

call toll-free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

When Using This Product

■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Capsule)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ difficulty in urination due to enlargement of the 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 the other upper respiratory allergies:

■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes

Section 42229-5 (42229-5)

THIS PRODUCT IS PACKAGED IN A TAMPER EVIDENT PACKAGE.

USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by the owners of Benadryl® Allergy LIQUI-GELS®

Manufactured for:

BIONPHARMA

Princeton, NJ 08540

MADE IN INDIA

Mfg. Lic. No.: TN00002123

2122718

L0000935

R1124

Purpose

Antihistamine

Warnings

■ May cause excitability especially in children.

■ May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

48's Count (48's count)

NDC 69452-453-09

†Compare to the active ingredient in Benadryl ^®Allergy LIQUI-GELS ^®†

a+ health

dye-free

allergy refief

diphenhydramine HCl capsules

USP, 25 mg

antihistamine

48 softgels**

**liquid-filled capsules

• sneezing • runny nose

• itchy, watery eyes • itchy throat or nose

Directions

■ Do not use for children under 6 years of age ■ do not take more than 6 doses in 24 hours

adults and children 12 years and over	1 to 2 capsules
children 6 to under 12 years	1 capsule
children under 6 years	do not use this product for children under 6 years of age

Do Not Use (Do not use)

■ Do not use for children under 6 years of age ■ with any other product containing diphenhydramine, even one used on skin.

Other Information (Other information)

■ store at 20°C to 25°C (68°F to 77°F)

■ avoid high humidity and excessive heat above 40°C (104°F).

■ protect from light

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

call toll-free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

When Using This Product (When using this product)

■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuously for more than 2 weeks

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

ask a health professional before use.

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.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 25 mg

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

■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ difficulty in urination due to enlargement of the prostate gland

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

if you are taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "■ temporarily relieves these symptoms due to hay fever or the other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes", "42229-5": "THIS PRODUCT IS PACKAGED IN A TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. †This product is not manufactured or distributed by the owners of Benadryl® Allergy LIQUI-GELS® Manufactured for: BIONPHARMA Princeton, NJ 08540 MADE IN INDIA Mfg. Lic. No.: TN00002123 2122718 L0000935 R1124", "Purpose": "Antihistamine", "Warnings": "■ May cause excitability especially in children. ■ May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.", "48's count": "NDC 69452-453-09 †Compare to the active ingredient in Benadryl ® Allergy LIQUI-GELS ®† a+ health dye-free allergy refief diphenhydramine HCl capsules USP, 25 mg antihistamine 48 softgels** **liquid-filled capsules • sneezing • runny nose • itchy, watery eyes • itchy throat or nose", "Directions": "■ Do not use for children under 6 years of age ■ do not take more than 6 doses in 24 hours adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use this product for children under 6 years of age", "Do not use": "■ Do not use for children under 6 years of age ■ with any other product containing diphenhydramine, even one used on skin.", "Other information": "■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F). ■ protect from light", "Inactive ingredients": "gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution", "Questions or comments?": "call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)", "When using this product": "■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each capsule)": "Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ difficulty in urination due to enlargement of the 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: 2026-02-15T12:07:24.138289 · Updated: 2026-03-14T23:10:46.361818