ALLERGY RELIEF- diphenhydramine hcl tablet 
Kareway Product, 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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Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCL 25mg

Purpose

Antihistamine

Uses

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over25 mg to 50 mg (1 to 2 tablets)
children 6 to under 12 years of age12.5** to 25 mg (1 tablet)
children under 6 years of ageask a doctor

**12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.

Other information

Inactive ingredients

microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, pregelatinized starch, dibasic calcium phosphate dihydrate, crospovidone, stearic acid, magnesium stearate, hypromellose, polyethyleneglycol, titanium dioxide, ethanol

Package label

Allergy Reliefimage of Allergy Relief carton

ALLERGY RELIEF 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0158
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
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
CROSPOVIDONE (UNII: 68401960MK)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ETHANETHIOL (UNII: M439R54A1D)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize9mm
FlavorImprint Code BE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0158-22 in 1 BOX
112 in 1 BLISTER PACK
2NDC:67510-0158-44 in 1 BOX
212 in 1 BLISTER PACK
3NDC:67510-0158-02 in 1 BOX
310 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/18/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 2/2013
Document Id: 55dc0484-2c66-4aed-a077-4b78f92d4810
Set id: 958daeb1-4a3c-4f8b-a8f8-b96a17041b85
Version: 4
Effective Time: 20130215
 
Kareway Product, Inc.