Chlorphen-12 (chlorpheniramine Maleate) Extended-release Tablets, 12 Mg

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 Povidone Propylene Glycol Sodium Benzoate Sodium Laureth Sulfate Titanium Dioxide Triethyl Citrate Fd&c Yellow No. 6 Talc

Identifiers & Packaging

Pill Appearance

Imprint: Chlorphen;12 Shape: round Color: orange Size: 7 mm Score: 1

Marketing Status

ANDA Active Since 2010-06-15

Medication Information

Purpose

Chlorpheniramine maleate 12 mg is used as an antihistamine.

Manufactured by:

KVK-Tech, Inc.

Newtown, PA 18940

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

Section 51945-4

New Look. Same Trusted Ingredient. MADE IN USA

NDC 10702-017-01

Chlorphen-12

Allergy

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

3 in 1

Fast Acting

Long Lasting

Less Drowsy

100 Tablets

Indoor & Outdoor Allergies

12-hour Extended-Release Tablets

Chlorpheniramine Maleate 12 mg/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

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

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

Principal Display Panel 24 Tablets Carton

New Look. Same Trusted Ingredient. MADE IN USA

NDC 10702-017-24

Chlorphen-12

Allergy

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

3 in 1

Fast Acting

Long Lasting

Less Drowsy

24 Tablets

Indoor & Outdoor Allergies

12-hour Extended-Release Tablets

Chlorpheniramine Maleate 12 mg/Antihistamine

Principal Display Panel 60 Tablets Container Label

New Look. Same Trusted Ingredient. MADE IN USA

NDC 10702-017-06

Chlorphen-12

Allergy

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

3 in 1

Fast Acting

Long Lasting

Less Drowsy

60 Tablets

Indoor & Outdoor Allergies

12-hour Extended-Release Tablets

Chlorpheniramine Maleate 12 mg/Antihistamine

Principal Display Panel 4 Tablets in A Sachet and A Carton of 50 Sachets

New Look. Same Trusted Ingredient. MADE IN USA

NDC 10702-017-04

NDC 10702-017-54

Chlorphen-12

Allergy

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat

3 in 1

Fast Acting

Long Lasting

Less Drowsy

4 Tablets in a sachet and a carton of 50 sachets

Indoor & Outdoor Allergies

12-hour Extended-Release Tablets

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

Section 51945-4 (51945-4)

New Look. Same Trusted Ingredient. MADE IN USA

NDC 10702-017-01

Chlorphen-12

Allergy

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

3 in 1

Fast Acting

Long Lasting

Less Drowsy

100 Tablets

Indoor & Outdoor Allergies

12-hour Extended-Release Tablets

Chlorpheniramine Maleate 12 mg/Antihistamine

Purpose (PURPOSE)

Chlorpheniramine maleate 12 mg is used as an antihistamine.

Manufactured by:

KVK-Tech, Inc.

Newtown, PA 18940

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

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

Principal Display Panel 24 Tablets Carton (Principal Display Panel - 24 Tablets Carton)

New Look. Same Trusted Ingredient. MADE IN USA

NDC 10702-017-24

Chlorphen-12

Allergy

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

3 in 1

Fast Acting

Long Lasting

Less Drowsy

24 Tablets

Indoor & Outdoor Allergies

12-hour Extended-Release Tablets

Chlorpheniramine Maleate 12 mg/Antihistamine

Principal Display Panel 60 Tablets Container Label (Principal Display panel - 60 Tablets Container Label)

New Look. Same Trusted Ingredient. MADE IN USA

NDC 10702-017-06

Chlorphen-12

Allergy

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

3 in 1

Fast Acting

Long Lasting

Less Drowsy

60 Tablets

Indoor & Outdoor Allergies

12-hour Extended-Release Tablets

Chlorpheniramine Maleate 12 mg/Antihistamine

Principal Display Panel 4 Tablets in A Sachet and A Carton of 50 Sachets (Principal Display Panel - 4 Tablets in a sachet and a carton of 50 sachets)

New Look. Same Trusted Ingredient. MADE IN USA

NDC 10702-017-04

NDC 10702-017-54

Chlorphen-12

Allergy

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat

3 in 1

Fast Acting

Long Lasting

Less Drowsy

4 Tablets in a sachet and a carton of 50 sachets

Indoor & Outdoor Allergies

12-hour Extended-Release Tablets

Chlorpheniramine Maleate 12 mg/Antihistamine

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Chlorphen-12 (chlorpheniramine Maleate) Extended-release Tablets, 12 Mg

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information