Cvs Pharmacy, Inc. Allergy Relief Drug Facts

Cvs Pharmacy, Inc. Allergy Relief Drug Facts
SPL v1
SPL
SPL Set ID 626aa162-f5e3-45c0-b5ac-d70bff255aed
Route
ORAL
Published
Effective Date 2017-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (12 mg)
Inactive Ingredients
Calcium Sulfate Carnauba Wax Silicon Dioxide Sucrose D&c Yellow No. 10 Fd&c Blue No. 2 Gelatin Low-substituted Hydroxypropyl Cellulose, Unspecified Lactose Monohydrate Magnesium Stearate Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Methylparaben Cellulose, Microcrystalline Polysorbate 80 Propylene Glycol Sodium Benzoate Sodium Laureth Sulfate Titanium Dioxide Triethyl Citrate Fd&c Yellow No. 6 Talc

Identifiers & Packaging

Marketing Status
ANDA Active Since 2010-06-15

Description

Antihistamine

Purpose

Chlorpheniramine maleate 12 mg is used as an antihistamine. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895


Medication Information

Purpose

Chlorpheniramine maleate 12 mg is used as an antihistamine.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Description

Antihistamine

Uses

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

sneezing

runny nose

itchy, watery eyes

itching of the nose or throat

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

excitability may occur, especially in children

drowsiness may occur

avoid alcoholic beverages

alchohol, sedatives and tranquilizers may increase drowsiness

use caution when driving a motor vehicle or operating machinery

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088

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

Directions

adults and children 12 years and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.

children under 12 years of age: ask a doctor

Other Information

each tablet contains: calcium 28 mg

store between 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F)

protect from excessive moisture

Inactive Ingredients

calcium sulfate, carnauba wax, colloidal silicon dioxide, confectioner’s sugar, D&C yellow No. 10 aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake, FD&C yellow No. 6, gelatin, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, propyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium lauryl sulphate, sucrose, talc, titanium dioxide, triethyl citrate

Principal Display Panel

Allergy Relief

CHLORPHENIRAMINE  MALEATE, 12 mg

Antihistamine

12 Hour Relief of:

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat

24 EXTENDED RELEASE TABLETS

Keep Out of Reach of Children

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

Chlorpheniramine Maleate 12 Mg

Antihistamine


Structured Label Content

Uses (USES)

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

sneezing

runny nose

itchy, watery eyes

itching of the nose or throat

Purpose (PURPOSE)

Chlorpheniramine maleate 12 mg is used as an antihistamine.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Warnings (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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

excitability may occur, especially in children

drowsiness may occur

avoid alcoholic beverages

alchohol, sedatives and tranquilizers may increase drowsiness

use caution when driving a motor vehicle or operating machinery

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088

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

Directions (DIRECTIONS)

adults and children 12 years and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.

children under 12 years of age: ask a doctor

Other Information (OTHER INFORMATION)

each tablet contains: calcium 28 mg

store between 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F)

protect from excessive moisture

Inactive Ingredients (INACTIVE INGREDIENTS)

calcium sulfate, carnauba wax, colloidal silicon dioxide, confectioner’s sugar, D&C yellow No. 10 aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake, FD&C yellow No. 6, gelatin, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, propyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium lauryl sulphate, sucrose, talc, titanium dioxide, triethyl citrate

Principal Display Panel

Allergy Relief

CHLORPHENIRAMINE  MALEATE, 12 mg

Antihistamine

12 Hour Relief of:

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat

24 EXTENDED RELEASE TABLETS

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.

Chlorpheniramine Maleate 12 Mg (Chlorpheniramine maleate 12 mg)

Antihistamine


Advanced Ingredient Data


Raw Label Data

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