BENADRYL ALLERGY ULTRATAB- diphenhydramine hydrochloride tablet, film coated

Benadryl Allergy Ultratab by

Drug Labeling and Warnings

Benadryl Allergy Ultratab by is a Otc medication manufactured, distributed, or labeled by Savings Distributors LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	B;WL;25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73097-004-50	25 in 1 CARTON	07/03/2019
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 73097-004-40	20 in 1 CARTON	07/03/2019
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 73097-004-02	1 in 1 CARTON	07/03/2019
3		2 in 1 POUCH; Type 0: Not a Combination Product

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)