drug facts

drug facts

SPL v5

SPL

SPL Set ID 4305ad50-d2a5-4d3e-9d92-cbf26e856a16

Route

oral

Published

Effective Date 2018-12-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

chlorpheniramine (4 mg)

Inactive Ingredients

d&c yellow no. 10 lactose, unspecified form magnesium stearate cellulose, microcrystalline stearic acid

Identifiers & Packaging

Pill Appearance

Shape: round Color: yellow Size: 8 mm Score: 2

Marketing Status

otc monograph drug active Since 2014-12-15

Purpose

Antihistamine

Description

Chlorpheniramine Maleate 4 mg

Medication Information

Warnings

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

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

Inactive Ingredients

D&C yellow #10 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid

Description

Chlorpheniramine Maleate 4 mg

Active Ingredient

Chlorpheniramine Maleate 4 mg

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

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 accidental overdose, contact a doctor or Poison Control Center immediately

Package/label Principal Display Panel

Allergy

Ask A Doctor Or Pharmacist Before Use If You

are taking sedatives or tranquilizers

Structured Label Content

Warnings

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

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

Inactive Ingredients

D&C yellow #10 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid

Active Ingredient (Active ingredient)

Chlorpheniramine Maleate 4 mg

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

If Pregnant Or Breast Feeding (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 accidental overdose, contact a doctor or Poison Control Center immediately

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

Allergy

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": "LACTOSE, UNSPECIFIED FORM", "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": "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", "Warnings": "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "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", "Inactive Ingredients": "D&C yellow #10 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid", "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", "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 accidental overdose, contact a doctor or Poison Control Center immediately", "Package/Label Principal Display Panel": "Allergy", "Ask a doctor or pharmacist before use if you": "are taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:20.706515 · Updated: 2026-03-14T23:01:49.492831