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Allergy

Major Pharmaceuticals

Major 44-194


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Chlorpheniramine maleate 4 mg

Antihistamine

  • 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

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.

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

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

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

(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.Allergy

Major 44-194

Allergy

Chlorpheniramine Maleate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-0012
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 4 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS LACTOSE
D&C YELLOW NO. 10
MAGNESIUM STEARATE
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
YELLOW 8 mm 44;194 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 100 in 1 BLISTER PACK
3 NDC:0904-0012-61 100 in 1 DOSE PACK
4 NDC:0904-0012-80 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1992-12-19


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Be sure to consult your doctor before taking any medication!
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