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Allergy

Aidarex Pharmaceuticals LLC

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

NDC 33261-0222-30

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

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

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

Allergy

Chlorpheniramine Maleate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33261-222(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 NDC:33261-222-30 30 in 1 BOTTLE, PLASTIC

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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