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Allergy Relief by Kareway Product, Inc.

Dosage form: tablet
Ingredients: CHLORPHENIRAMINE MALEATE 4mg
Labeler: Kareway Product, Inc.
NDC Code: 67510-0159

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.

Drug Facts

Active ingredient (in each tablet)

Chlorpheniramine Maleate 4mg

Purpose

Antihistamine

Uses
  • temporarily relieves minor symptoms due to hay fever or other upper respiratory allergies such as:
    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy throat

Warnings

Ask a doctor before use it you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urinating due to enlargement of the prostate gland
  • asthma, shortness of breath


Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product
  • you may get drowsy
  • 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 accidental overdose get medical help or contact a Poison Control Center right away.

Directions
  • Adults and children 12 years and over: Take one (1) tablet every 4 to 6 hours. Do not exceed 6 tablets in 24 hours.
  • Children 12 years and under: Consult a physician before use

Other information
  • store at 20° to 25°C (68°-67°F)
  • protect from excessive moisture
  • Do not exceed recommended dose

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

ALLERGY RELIEF 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0159
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE WAX 
ANHYDROUS LACTOSE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STARCH, CORN 
CROSPOVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
HYPROMELLOSES 
FD&C RED NO. 40 
FD&C YELLOW NO. 5 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
ETHANETHIOL 
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize9mm
FlavorImprint CodeBT
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-0159-22 BLISTER PACK (BLISTER PACK) in 1 BOX
112 TABLET (TABLET) in 1 BLISTER PACK
2NDC:67510-0159-02 BLISTER PACK (BLISTER PACK) in 1 BOX
210 TABLET (TABLET) in 1 BLISTER PACK
3NDC:67510-0159-44 BLISTER PACK (BLISTER PACK) in 1 BOX
312 TABLET (TABLET) 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: 02/2013
 
Kareway Product, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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