ALLERGY RELIEF- chlorpheniramine maleate 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)

Chlorpheniramine Maleate 4mg

Purpose

Antihistamine

Uses

Warnings


Ask a doctor before use it 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


Other information

Inactive ingredients

microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, corn starch glycolate, crospovidone, silicon dioxide, stearic acid, hypromellose, FDC red no.40, FDC yellow no.5, titanium dioxide, polyethyleneglycol, ethanol

Package label

image of Allergy Relief carton

ALLERGY RELIEF 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0159
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 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)  
CROSPOVIDONE (UNII: 68401960MK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
ETHANETHIOL (UNII: M439R54A1D)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize9mm
FlavorImprint Code BT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0159-22 in 1 BOX
112 in 1 BLISTER PACK
2NDC:67510-0159-02 in 1 BOX
210 in 1 BLISTER PACK
3NDC:67510-0159-44 in 1 BOX
312 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: 1cf99cf6-1836-4888-a5cc-f7ea5c6bb5f0
Set id: 2c6f254b-0453-4c79-8b3e-8373335b474e
Version: 4
Effective Time: 20130215
 
Kareway Product, Inc.