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benadryl allergy ultratab
SPL v1
SPL
SPL Set ID 8d59d121-62a8-c43b-e053-2a95a90a5847
Route
oral
Published
Effective Date 2019-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
carnauba wax croscarmellose sodium d&c red no. 27 aluminum lake anhydrous dibasic calcium phosphate magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: B;WL;25 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
otc monograph final active Since 2019-07-03
Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Medication Information

Active Ingredient

Diphenhydramine HCl 25 mg

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

Purpose

Antihistamine

Directions

■ take every 4 to 6 hours, or as directed by a doctor

■ do not take more than 6 times in 24 hours

adults and children 12 years and over 1 to 2 tablets

children 6 to under 12 years 1 tablet

children under 6 years do not use

Other Information

■ each tablet contains: calcium 15 mg

■ store between 20-25°C (68-77°F). Protect from light.

■ do not use if pouch is torn or damaged

Inactive Ingredients

carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Description

Diphenhydramine HCl 25 mg

Do Not Use

■ to make a child sleepy

■ with any other product containing diphenhydramine, even one used on skin

Drug Facts

Package Label

Questions Or Comments?

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

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.

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

Active Ingredient (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

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

Purpose

Antihistamine

Directions

■ take every 4 to 6 hours, or as directed by a doctor

■ do not take more than 6 times in 24 hours

adults and children 12 years and over 1 to 2 tablets

children 6 to under 12 years 1 tablet

children under 6 years do not use

Other Information (Other information)

■ each tablet contains: calcium 15 mg

■ store between 20-25°C (68-77°F). Protect from light.

■ do not use if pouch is torn or damaged

Inactive Ingredients (Inactive ingredients)

carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Do Not Use (Do not use)

■ to make a child sleepy

■ with any other product containing diphenhydramine, even one used on skin

Drug Facts

Package Label

Questions Or Comments? (Questions or comments?)

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

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.

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:50.283211 · Updated: 2026-03-14T22:55:34.309870