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Benadryl Allergy Ultratab Prescribing Information

Package insert / product label
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 Feb 6, 2024.

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Indications and Usage for Benadryl Allergy Ultratab

■ 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)

Benadryl Allergy Ultratab Dosage and Administration

■ 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

Package Label

BENADRYL ALLERGY ULTRATAB
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73097-004(NDC:50580-226)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint CodeB;WL;25
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73097-004-5025 in 1 CARTON07/03/2019
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:73097-004-4020 in 1 CARTON07/03/2019
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:73097-004-021 in 1 CARTON07/03/2019
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/03/2019
Labeler - Savings Distributors LLC (010527359)

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