Chlorpheniramine Maleate

Chlorpheniramine Maleate
SPL v1
SPL
SPL Set ID e041ed3c-36d8-4a51-9ebc-b364be9016a4
Route
ORAL
Published
Effective Date 2010-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg)

Identifiers & Packaging

Pill Appearance
Shape: round Color: yellow Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-08-25
Description

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Chlorpheniramine maleate 4 mg

Uses
  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes
Directions

take every 4 to 6 hours, not more than 6 doses in 24 hours

adults and children 12 years of age and over 1 tablet (4 mg)
children 6 to under 12 years of age 1/2 tablet (2 mg)
children 4 to under 6 years of age

do not use unless

directed by a doctor
children under 4 years of age do not use
Do Not Use

to make a child sleepy

Package Label
Blister of 30 Tablets
Other Information
  • store at room temperature
  • protect from moisture
Inactive Ingredients

corn starch, D&C yellow no. 10, lactose, magnesium stearate

Questions Or Comments?

Distributed by:

Goldline Laboratories, Inc.

Miami, FL 33137 U.S.A.

1-888-838-2872

Repackaged by:



Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--08/2010--NJW

When Using This Product
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
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
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Uses (USES)
  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes
Purpose (PURPOSE)

Antihistamine

Directions (DIRECTIONS)

take every 4 to 6 hours, not more than 6 doses in 24 hours

adults and children 12 years of age and over 1 tablet (4 mg)
children 6 to under 12 years of age 1/2 tablet (2 mg)
children 4 to under 6 years of age

do not use unless

directed by a doctor
children under 4 years of age do not use
Do Not Use (Do not use)

to make a child sleepy

Package Label
Blister of 30 Tablets
Other Information (OTHER INFORMATION)
  • store at room temperature
  • protect from moisture
Inactive Ingredients (INACTIVE INGREDIENTS)

corn starch, D&C yellow no. 10, lactose, magnesium stearate

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Distributed by:

Goldline Laboratories, Inc.

Miami, FL 33137 U.S.A.

1-888-838-2872

Repackaged by:



Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--08/2010--NJW

When Using This Product (When using this product)
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
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
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
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: 2026-02-15T11:55:07.182279 · Updated: 2026-03-14T22:52:27.184723