277 - Allergy

SPL v6

SPL

SPL Set ID 2051247f-ce64-4cf5-b449-9ca14c43ab86

Route

ORAL

Published

Effective Date 2016-12-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg)

Inactive Ingredients

D&c Yellow No. 10 Magnesium Stearate Microcrystalline Cellulose Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: AZ;246 Shape: round Color: yellow Size: 8 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-12-15

Description

Chlorpheniramine Maleate 4 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Chlorpheniramine Maleate 4 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■ sneezing

■ runny nose

■ itchy watery eyes

■ itching of the nose or throat

Directions

■ take every 4 to 6 hours

■ do not take more than 6 doses in 24 hours

■ Adults and children 12 years and over: 1 tablet

■ Children 6 to under 12 years: 1/2 tablet

■ Children under 6 years: consult a doctor

Active Ingredient

Chlorpheniramine Maleate 4 mg

Other Information

■ Store at room temperature in a dry place

Inactive Ingredients

D&C Yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid. May contain starch.

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Allergy Relief

When Using This Product

■ marked drowsiness may occur

■ avoid alcoholic beverages

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ be careful when drivinga motor vehicle or operating machinery

■ excitability may occur especially in children

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Ask A Doctor Before Use If You Have

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma or

■ 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

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■ sneezing

■ runny nose

■ itchy watery eyes

■ itching of the nose or throat

Purpose

Antihistamine

Directions

■ take every 4 to 6 hours

■ do not take more than 6 doses in 24 hours

■ Adults and children 12 years and over: 1 tablet

■ Children 6 to under 12 years: 1/2 tablet

■ Children under 6 years: consult a doctor

Active Ingredient (Active ingredient)

Chlorpheniramine Maleate 4 mg

Other Information (Other information)

■ Store at room temperature in a dry place

Inactive Ingredients (Inactive ingredients)

D&C Yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid. May contain starch.

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

Allergy Relief

When Using This Product (When using this product)

■ marked drowsiness may occur

■ avoid alcoholic beverages

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ be careful when drivinga motor vehicle or operating machinery

■ excitability may occur especially in children

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

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

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 or

■ trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You (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": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ sneezing ■ runny nose ■ itchy watery eyes ■ itching of the nose or throat", "Purpose": "Antihistamine", "Directions": "■ take every 4 to 6 hours ■ do not take more than 6 doses in 24 hours ■ Adults and children 12 years and over: 1 tablet ■ Children 6 to under 12 years: 1/2 tablet ■ Children under 6 years: consult a doctor", "Active ingredient": "Chlorpheniramine Maleate 4 mg", "Other information": " ■ Store at room temperature in a dry place", "Inactive ingredients": "D&C Yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid. May contain starch.", "Pregnancy/Breastfeeding": "ask a health professional before use.", "Principal Display Panel": " Allergy Relief", "When using this product": "■ marked drowsiness may occur ■ avoid alcoholic beverages ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful when drivinga motor vehicle or operating machinery ■ excitability may occur especially in children", "Keep out of reach of children": "In case of accidental overdose, contact a doctor or Poison Control Center immediately.", "Ask a doctor before use if you have": "■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma or ■ trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you": "are taking sedatives or tranquilizers"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:25.920339 · Updated: 2026-03-14T23:01:24.251815