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Allergy by Major Pharmaceuticals

Dosage form: tablet
Ingredients: CHLORPHENIRAMINE MALEATE 4mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-0012

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.

Major 44-194

Active ingredient (in each tablet)

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

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

Warnings

Ask a doctor before use if you have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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 overdose, get medical help or contact a Poison Control Center right away.

Directions
adults and children 12 years of age and older 1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours
children 6 to under 12 years of age
1/2 tablet (break tablet in half) every 4 to 6 hours.  Do not exceed 3 tablets in 24 hours.
children under 6 years of age
 do not use this product in children under 6 years of age

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from excessive moisture
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-0012-24

Allergy
Tablets
Antihistamine

RELIEVES: Sneezing,
Itchy, Watery Eyes,
Itchy Throat, Runny Nose

*Compare to the active ingredient in Chlor-Trimeton® Allergy Tablets

Chlorpheniramine maleate 4 mg EACH

4 hour
24 TABLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Chlor-Trimeton® Allergy Tablets.
50844    REV0512K19408

Distributed by Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA
REV. 05/12
M-17

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Major 44-194

ALLERGY 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-0012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize8mm
FlavorImprint Code44;194
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-0012-241 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
124 TABLET (24 TABLET) in 1 BLISTER PACK
2NDC:0904-0012-591 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
2100 TABLET (100 TABLET) in 1 BLISTER PACK
3NDC:0904-0012-61100 TABLET (100 TABLET) in 1 DOSE PACK
4NDC:0904-0012-801000 TABLET (1000 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/19/1992
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0904-0012)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0904-0012)

Revised: 06/2013
 
Major Pharmaceuticals

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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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