Diphenhydramine Hcl 50mg, A+ Health, Allergy Relief

SPL v3

SPL

SPL Set ID 1f737b76-14b5-618a-e063-6294a90a19c2

Route

ORAL

Published

Effective Date 2024-08-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Polyethylene Glycol 600 Sorbitan Gelatin Polyethylene Glycol 400 Water Glycerin Propylene Glycol Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: DF50 Shape: oval Color: white Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-10-01

Description

Diphenhydramine HCl 50 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 50 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

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by the owners of Benadryl® Allergy Extra Strength.

Manufactured for:

Bionpharma

Princeton, NJ 08540

Mfg. Lic. No.: TN00002123

L0000864

R0524

2122631

Warnings

■ May cause excitability especially in children.

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

Directions

adults and children 12 years and over	■ take 1 capsule every 4 to 6 hours, or as directed by a doctor ■ do not take more than 6 capsules in 24 hours
children under 12 years	do not use

Do Not Use

■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin.

100's Count

^†Compare to the active ingredient in Benadryl® Allergy Extra Strength

NDC 69452-452-20

a+ health ^TM

dye-free

extra strength

allergy relief

diphenhydramine HCl capsules USP, 50 mg

antihistamine

• sneezing • runny nose

• itchy, watery eyes • itchy throat or nose

100 softgels **

**liquid-filled capsules

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, polyethylene glycol 600, 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

Keep Out of Reach of Children.

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Capsule)

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have

■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

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)

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by the owners of Benadryl® Allergy Extra Strength.

Manufactured for:

Bionpharma

Princeton, NJ 08540

Mfg. Lic. No.: TN00002123

L0000864

R0524

2122631

Purpose

Antihistamine

Warnings

■ May cause excitability especially in children.

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

Directions

adults and children 12 years and over	■ take 1 capsule every 4 to 6 hours, or as directed by a doctor ■ do not take more than 6 capsules in 24 hours
children under 12 years	do not use

Do Not Use (Do not use)

■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin.

100's Count (100's count)

^†Compare to the active ingredient in Benadryl® Allergy Extra Strength

NDC 69452-452-20

a+ health ^TM

dye-free

extra strength

allergy relief

diphenhydramine HCl capsules USP, 50 mg

antihistamine

• sneezing • runny nose

• itchy, watery eyes • itchy throat or nose

100 softgels **

**liquid-filled capsules

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, polyethylene glycol 600, 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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

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

ask a health professional before use.

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

Diphenhydramine HCl 50 mg

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

■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use (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 the other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes", "42229-5": "DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. †This product is not manufactured or distributed by the owners of Benadryl® Allergy Extra Strength. Manufactured for: Bionpharma Princeton, NJ 08540 Mfg. Lic. No.: TN00002123 L0000864 R0524 2122631", "Purpose": "Antihistamine", "Warnings": "■ May cause excitability especially in children. ■ May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.", "Directions": "adults and children 12 years and over ■ take 1 capsule every 4 to 6 hours, or as directed by a doctor ■ do not take more than 6 capsules in 24 hours children under 12 years do not use", "Do not use": "■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin.", "100's count": "† Compare to the active ingredient in Benadryl® Allergy Extra Strength NDC 69452-452-20 a+ health TM dye-free extra strength allergy relief diphenhydramine HCl capsules USP, 50 mg antihistamine • sneezing • runny nose • itchy, watery eyes • itchy throat or nose 100 softgels * * **liquid-filled capsules", "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, polyethylene glycol 600, 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", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Centre right away.", "If pregnant or breast- feeding,": "ask a health professional before use.", "Active ingredient (in each capsule)": "Diphenhydramine HCl 50 mg", "Ask a doctor before use if you have": "■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland ■ a breathing problem such as emphysema or chronic bronchitis", "Ask a doctor or pharmacist before use": "if you are taking sedatives or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:23.110320 · Updated: 2026-03-14T23:13:57.106193