Chlorpheniramine Maleate 4 Mg

SPL v8

SPL

SPL Set ID 54681242-c861-4415-b5c0-d3ab55b62be1

Route

ORAL

Published

Effective Date 2024-05-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg)

Inactive Ingredients

D&c Yellow No. 10 Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Magnesium Stearate Microcrystalline Cellulose Starch, Corn Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: AP;016 Shape: round Color: yellow Size: 8 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-11-01

Description

Drug Facts

Purpose

Antihistamine

How Supplied

NDC: 71335-0963-1: 30 Tablets in a BOTTLE NDC: 71335-0963-2: 60 Tablets in a BOTTLE NDC: 71335-0963-3: 100 Tablets in a BOTTLE NDC: 71335-0963-4: 120 Tablets in a BOTTLE NDC: 71335-0963-5: 40 Tablets in a BOTTLE NDC: 71335-0963-6: 24 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Antihistamine

How Supplied

NDC: 71335-0963-1: 30 Tablets in a BOTTLE

NDC: 71335-0963-2: 60 Tablets in a BOTTLE

NDC: 71335-0963-3: 100 Tablets in a BOTTLE

NDC: 71335-0963-4: 120 Tablets in a BOTTLE

NDC: 71335-0963-5: 40 Tablets in a BOTTLE

NDC: 71335-0963-6: 24 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Drug Facts

Uses

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

runny nose
sneezing
itchy nose or throat
itchy, watery eyes

Section 34072-9

When using this product

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Drug Facts continued on back of label

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 51945-4

Chlorpheniramine Maleate 4 mg Tablet

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Ask a doctor before use if you have

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

Directions

adults and children 12 years and over	take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours
children 6 years to under 12 years	take 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours
children under 6 years	do not use

Other Information

each tablet contains: calsium 40 mg
store at 15°-30°C (59°-86°F)

Inactive Ingredients

croscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

Questions Or Comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Tablet)

Chlorpheniramine maleate 4 mg

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

Section 34072-9 (34072-9)

When using this product

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Drug Facts continued on back of label

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 51945-4 (51945-4)

Chlorpheniramine Maleate 4 mg Tablet

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine

Warnings

Ask a doctor before use if you have

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

Directions

adults and children 12 years and over	take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours
children 6 years to under 12 years	take 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours
children under 6 years	do not use

How Supplied (HOW SUPPLIED)

NDC: 71335-0963-1: 30 Tablets in a BOTTLE

NDC: 71335-0963-2: 60 Tablets in a BOTTLE

NDC: 71335-0963-3: 100 Tablets in a BOTTLE

NDC: 71335-0963-4: 120 Tablets in a BOTTLE

NDC: 71335-0963-5: 40 Tablets in a BOTTLE

NDC: 71335-0963-6: 24 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (Other information)

each tablet contains: calsium 40 mg
store at 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

Questions Or Comments? (Questions or comments?)

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Chlorpheniramine maleate 4 mg

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": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "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": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "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", "34072-9": "When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Drug Facts continued on back of label", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "51945-4": "Chlorpheniramine Maleate 4 mg Tablet", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "Warnings": "Ask a doctor before use if you have glaucoma trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis", "Directions": "adults and children 12 years and over take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours children 6 years to under 12 years take 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours children under 6 years do not use", "HOW SUPPLIED": "NDC: 71335-0963-1: 30 Tablets in a BOTTLE NDC: 71335-0963-2: 60 Tablets in a BOTTLE NDC: 71335-0963-3: 100 Tablets in a BOTTLE NDC: 71335-0963-4: 120 Tablets in a BOTTLE NDC: 71335-0963-5: 40 Tablets in a BOTTLE NDC: 71335-0963-6: 24 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "Other information": "each tablet contains: calsium 40 mg store at 15°-30°C (59°-86°F)", "Inactive ingredients": "croscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide", "Questions or comments?": "call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday", "Active ingredient (in each tablet)": "Chlorpheniramine maleate 4 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:06.243014 · Updated: 2026-03-14T23:02:58.626725