Major 44-194

Major 44-194
SPL v1
SPL
SPL Set ID 59e179f8-acdb-4306-bd4f-24350d9171b1
Route
ORAL
Published
Effective Date 2013-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg)
Inactive Ingredients
Anhydrous Lactose D&c Yellow No. 10 Magnesium Stearate Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance
Imprint: 44;194 Shape: round Color: yellow Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 1992-12-19
Description

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Chlorpheniramine maleate 4 mg

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
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

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.

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.

Active Ingredient (in Each Tablet)

Chlorpheniramine maleate 4 mg

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.

Structured Label Content

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
Purpose

Antihistamine

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 (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

(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.

When Using This Product (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Chlorpheniramine maleate 4 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:43.946133 · Updated: 2026-03-14T22:53:39.434183