BENADRYL- diphenhydramine hydrochloride tablet, film coated

Benadryl by

Drug Labeling and Warnings

Benadryl by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 carton is opened or if blister unit is broken

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)

PRINCIPAL DISPLAY PANEL

NDC: 50580-226-51

Benadryl®

ALLERGY

Diphenhydramine HCl 25mg | Antihistamine

✓ Sneezing
✓ Runny Nose
✓ Itchy, Watery Eyes
✓ Itchy Throat

ULTRATABS®*
*small tablet size

actual size

24 TABLETS

INGREDIENTS AND APPEARANCE

BENADRYL  
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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 (UNII: 2LRS185U6K)
Aluminum Oxide (UNII: LMI26O6933)
Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
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: 50580-226-50	1 in 1 CARTON	06/04/2012
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 50580-226-51	2 in 1 CARTON	06/04/2012
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 50580-226-53	2 in 1 POUCH; Type 0: Not a Combination Product	06/04/2012
4	NDC: 50580-226-54	60 in 1 CARTON	07/27/2015
4		2 in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 50580-226-62	4 in 1 CARTON	01/02/2017
5		2 in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 50580-226-52	4 in 1 CARTON	06/04/2012
6		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 50580-226-56	3 in 1 PACKAGE	02/01/2013
7	NDC: 50580-226-52	4 in 1 CARTON
7		12 in 1 BLISTER PACK; 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	09/01/2008

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)