Chlorpheniramine Maleate

SPL v1

SPL

SPL Set ID 4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f

Route

ORAL

Published

Effective Date 2011-01-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg)

Inactive Ingredients

D&c Yellow No. 10 Lactose Magnesium Stearate Cellulose, Microcrystalline Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: 44;194 Shape: round Color: yellow Size: 8 mm Score: 2

Marketing Status

OTC MONOGRAPH FINAL Active Since 2011-01-10

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

Active Ingredient

Chlorpheniramine maleate 4 mg

Inactive Ingredients

D&C yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch.

Questions Or Comments?

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150, USA

1-734-743-6000

Repackaged by:

Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--01/2011--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.

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

Package/label Principal Display Panel

Blister of 30 Tablets

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Uses

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

Purpose

Antihistamine

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

Active Ingredient (Active ingredient)

Chlorpheniramine maleate 4 mg

Inactive Ingredients (Inactive ingredients)

D&C yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150, USA

1-734-743-6000

Repackaged by:

Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--01/2011--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.

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Blister of 30 Tablets

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

[{"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing itchy nose or throat itchy, watery eyes", "Purpose": "Antihistamine", "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", "Active ingredient": "Chlorpheniramine maleate 4 mg", "Inactive ingredients": "D&C yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch.", "QUESTIONS OR COMMENTS?": "Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150, USA 1-734-743-6000 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--01/2011--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.", "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", "Package/Label Principal Display Panel": "Blister of 30 Tablets", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:11.638091 · Updated: 2026-03-14T22:52:33.958895