BERKLEY AND JENSEN ALLERGY- diphenhydramine hydrochloride tablet
BJWC

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.

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BJWC Allergy Drug Facts

Active ingredient (in each tablet)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

temporarily relieves symptoms due to hay fever, other upper respiratory allergies and the common cold

Warnings

Do not use

•: with any other product containing diphenhydramine, even one used on skin
•: to make a child sleepy

Ask a doctor before use if you have

•: glaucoma
•: trouble urinating due to an enlarged prostate gland
•: a breathing problem such as emphysema or chronic bronchitis

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
•: excitability may occur, especially in children
•: alcohol, sedatives and tranquilizers may increase drowsiness
•: be careful when driving a motor vehicle or operating machinery

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.

Directions

•: take every 4 to 6 hours, not more than 6 doses in 24 hours

adults and children 12 years of age and over	1 or 2 tablets
children 6 to under 12 years of age	1 tablet
children 4 to under 6 years of age	do not use unless directed by a doctor
children under 4 years of age	do not use

Other information

•: each tablet contains: calcium 20 mg
•: store at 20°-25°C

Inactive ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions?

1-800-934-1204

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT OF BENADRYL® ALLERGY

Allergy

Tablets

Diphenhydramine Hydrochloride 25 mg

Antihistamine

For Allergy Relief

Sneezing

Itchy, watery eyes

Runny nose

Itchy throat

25 mg each

Easy to swallow

BERKLEY AND JENSEN ALLERGY
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68391-479
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)

Product Characteristics
Color	PINK (dark)	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	L479
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68391-479-79	400 in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2008	07/03/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/31/2008	07/03/2014

Labeler - BJWC (159082692)

Revised: 11/2017

Document Id: 544b7766-57f7-4964-866b-af0d923802b2

Set id: 379d9648-1143-4415-a528-3b18cddcfa9e

Version: 2

Effective Time: 20171118

BJWC