ALLERGY- diphenhydramine hydrochloride tablet 
Western Family Foods Inc

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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Western Family Allergy Drug Facts

Active ingredient (in each tablet)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

•
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
•
runny nose
•
sneezing
•
itchy, watery eyes
•
itchy nose or throat
•
temporarily relieves these symptoms of the common cold:
•
runny nose
•
sneezing

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 or comments?

1-800-719-9260

Principal Display Panel

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat

Complete

Allergy

Diphenhydramine Hydrochloride 25 mg

ANTIHISTAMINE

MEDICINE

COMPARE TO BENADRYL® ALLERGY ULTRATAB® active ingredient

100 TABLETS

Allergy Carton Image 1
Allergy Carton Image 2
ALLERGY 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-479
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)  
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
ColorPINK (dark) Scoreno score
ShapeCAPSULESize10mm
FlavorImprint Code L479
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-479-621 in 1 CARTON02/25/200308/17/2017
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55312-479-781 in 1 CARTON02/25/200308/17/2017
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/25/200308/17/2017
Labeler - Western Family Foods Inc (192166072)

Revised: 11/2017
Document Id: 9f49ffb0-d98f-4c77-9f00-d4082471b9f0
Set id: f178c403-e285-4e09-95ed-14e71a599285
Version: 2
Effective Time: 20171127
 
Western Family Foods Inc