Major 44-194

Major 44-194
SPL v104
SPL
SPL Set ID c948e612-a491-4ad0-adb9-cf31ef76e4d8
Route
ORAL
Published
Effective Date 2024-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;194 Shape: round Color: yellow Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 1992-12-19
Description

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

How Supplied

Chlorpheniramine Maleate 4 mg NDC 71335-2056-1: 30 Tablets in a BOTTLE NDC 71335-2056-2: 60 Tablets in a BOTTLE NDC 71335-2056-3: 100 Tablets in a BOTTLE NDC 71335-2056-4: 120 Tablets in a BOTTLE NDC 71335-2056-5: 40 Tablets in a BOTTLE NDC 71335-2056-6: 24 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Antihistamine

How Supplied

Chlorpheniramine Maleate 4 mg

  • NDC 71335-2056-1: 30 Tablets in a BOTTLE
  • NDC 71335-2056-2: 60 Tablets in a BOTTLE
  • NDC 71335-2056-3: 100 Tablets in a BOTTLE
  • NDC 71335-2056-4: 120 Tablets in a BOTTLE
  • NDC 71335-2056-5: 40 Tablets in a BOTTLE
  • NDC 71335-2056-6: 24 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Chlorpheniramine maleate 4 mg

Uses

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
Section 51945-4

Chlorpheniramine Maleate 4mg Tablet

Directions
  • take every 4 to 6 hours, or as directed by a doctor
adults and children 12 years and over 1 tablet. Do not exceed 6 tablets in 24 hours.
children 6 to under 12 years 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
children under 6 years do not use
Do Not Use

to make a child sleepy.

Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • 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?

1-800-426-9391

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
  • a breathing problem such as emphysema or chronic bronchitis  
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

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
Section 51945-4 (51945-4)

Chlorpheniramine Maleate 4mg Tablet

Purpose

Antihistamine

Directions
  • take every 4 to 6 hours, or as directed by a doctor
adults and children 12 years and over 1 tablet. Do not exceed 6 tablets in 24 hours.
children 6 to under 12 years 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
children under 6 years do not use
Do Not Use (Do not use)

to make a child sleepy.

How Supplied (HOW SUPPLIED)

Chlorpheniramine Maleate 4 mg

  • NDC 71335-2056-1: 30 Tablets in a BOTTLE
  • NDC 71335-2056-2: 60 Tablets in a BOTTLE
  • NDC 71335-2056-3: 100 Tablets in a BOTTLE
  • NDC 71335-2056-4: 120 Tablets in a BOTTLE
  • NDC 71335-2056-5: 40 Tablets in a BOTTLE
  • NDC 71335-2056-6: 24 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • 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?)

1-800-426-9391

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)
  • a breathing problem such as emphysema or chronic bronchitis  
  • glaucoma
  • difficulty in urination due to enlargement of the 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: 2026-02-15T12:06:06.611726 · Updated: 2026-03-14T23:08:42.212838