Anti-allergy Tablets Antihistamine

SPL v2

SPL

SPL Set ID 316db99f-5a13-48e0-9a6b-ab7a76fe4d28

Route

ORAL

Published

Effective Date 2017-10-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: AP;016 Shape: round Color: yellow Size: 8 mm Score: 2

Marketing Status

OTC MONOGRAPH FINAL Active Since 2015-05-01

Description

(in each tablet) Chlorpheniramine Maleate 4 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

(in each tablet) Chlorpheniramine Maleate 4 mg

Uses

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

runny nose
itchy nose or throat
sneezing
itchy, watery eyes

Warnings

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

When using this product

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives & tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating a machine
excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use.

Directions[/s]

Adults & 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 ½ tablet every 4 to 6 hours not more than 3 tablets in 24 hours
children under 6 years	do not use

Active Ingredient

(in each tablet)

Chlorpheniramine Maleate 4 mg

Other Information

each tablet contains: calcium 40 mg
store between 15°-30°C (59°-86°F)
protect from moisture

Inactive Ingredients

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

Questions Or Comments

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED

Principal Display Panel

Chlorpheniramine Maleate 4 mg

Antihistamine

NDC: 54738-103-01 - 100 CPM tablets

NDC: 54738-103-03 - 1000 CPM tablets

NDC: 54738-103-14 - 24 CPM tablets

Keep Out of Reach of Children

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

Structured Label Content

Uses

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

runny nose
itchy nose or throat
sneezing
itchy, watery eyes

Purpose

Antihistamine

Warnings

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

When using this product

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives & tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating a machine
excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use.

Directions[/s] (Directions[/S])

Adults & 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 ½ tablet every 4 to 6 hours not more than 3 tablets in 24 hours
children under 6 years	do not use

Active Ingredient

(in each tablet)

Chlorpheniramine Maleate 4 mg

Other Information

each tablet contains: calcium 40 mg
store between 15°-30°C (59°-86°F)
protect from moisture

Inactive Ingredients

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

Questions Or Comments (Questions or Comments)

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Chlorpheniramine Maleate 4 mg

Antihistamine

NDC: 54738-103-01 - 100 CPM tablets

NDC: 54738-103-03 - 1000 CPM tablets

NDC: 54738-103-14 - 24 CPM tablets

Keep Out of Reach of Children

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies : runny nose itchy nose or throat sneezing itchy, watery eyes", "Purpose": "Antihistamine", "Warnings": "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 When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives & tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating a machine excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use.", "Directions[/S]": "Adults & 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 ½ tablet every 4 to 6 hours not more than 3 tablets in 24 hours children under 6 years do not use", "Active Ingredient": "(in each tablet) Chlorpheniramine Maleate 4 mg", "Other Information": "each tablet contains: calcium 40 mg store between 15°-30°C (59°-86°F) protect from moisture", "Inactive Ingredients": "croscarmellose sodium, D&C yellow #10 (al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch", "Questions or Comments": "call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED", "PRINCIPAL DISPLAY PANEL": "Chlorpheniramine Maleate 4 mg Antihistamine NDC: 54738-103-01 - 100 CPM tablets NDC: 54738-103-03 - 1000 CPM tablets NDC: 54738-103-14 - 24 CPM tablets", "Keep Out of Reach of Children": "In case of overdose, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:26.097369 · Updated: 2026-03-14T22:54:52.931560