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Benadryl Allergy Ultratab

Package insert / prescribing information
Generic name: diphenhydramine hydrochloride
Dosage form: tablet, film coated
Drug classes: Anticholinergic antiemetics, Anticholinergic antiparkinson agents, Antihistamines, Miscellaneous anxiolytics, sedatives and hypnotics

Medically reviewed by Drugs.com. Last updated on Jun 21, 2022.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

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

Warnings

Do not use

■ to make a child sleepy

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

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

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

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. (1-800-222-1222)

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

Questions or comments?

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

Package Label

Benadryl Allergy Ultratab
diphenhydramine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73097-004(NDC:50580-226)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
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
Product Characteristics
Color pink Score no score
Shape OVAL Size 11mm
Flavor Imprint Code B;WL;25
Contains
Packaging
# Item Code Package Description
1 NDC:73097-004-50 25 POUCH in 1 CARTON
1 2 TABLET, FILM COATED in 1 POUCH
2 NDC:73097-004-40 20 POUCH in 1 CARTON
2 2 TABLET, FILM COATED in 1 POUCH
3 NDC:73097-004-02 1 POUCH in 1 CARTON
3 2 TABLET, FILM COATED in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/03/2019
Labeler - Savings Distributors LLC (010527359)
Savings Distributors LLC

Frequently asked questions

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