Allergy

Allergy
SPL v20
SPL
SPL Set ID b199b5ee-fff3-4746-be68-a04060586f8e
Route
ORAL
Published
Effective Date 2024-07-18
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

Product: 50090-0049 NDC: 50090-0049-6 20 TABLET in a BOTTLE NDC: 50090-0049-7 60 TABLET in a BOTTLE NDC: 50090-0049-0 100 TABLET in a BOTTLE / 1 in a CARTON NDC: 50090-0049-1 10 TABLET in a BOTTLE

Medication Information

Purpose

Antihistamine

How Supplied

Product: 50090-0049

NDC: 50090-0049-6 20 TABLET in a BOTTLE

NDC: 50090-0049-7 60 TABLET in a BOTTLE

NDC: 50090-0049-0 100 TABLET in a BOTTLE / 1 in a CARTON

NDC: 50090-0049-1 10 TABLET in a BOTTLE

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
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
Chlorpheniramine Maleate
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
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)

Product: 50090-0049

NDC: 50090-0049-6 20 TABLET in a BOTTLE

NDC: 50090-0049-7 60 TABLET in a BOTTLE

NDC: 50090-0049-0 100 TABLET in a BOTTLE / 1 in a CARTON

NDC: 50090-0049-1 10 TABLET in a BOTTLE

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
Chlorpheniramine Maleate
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

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Source: dailymed · Ingested: 2026-02-15T12:03:18.838050 · Updated: 2026-03-14T23:03:18.838207