Medique Chlorphen

Medique Chlorphen
SPL v5
SPL
SPL Set ID b3d5d161-8d4c-f1bb-e053-2a95a90a5bc5
Route
ORAL
Published
Effective Date 2020-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg)
Inactive Ingredients
Starch, Corn Anhydrous Lactose Cellulose, Microcrystalline Magnesium Stearate D&c Yellow No. 10 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: 44;194 Shape: round Color: yellow Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-25

Description

Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg


Medication Information

Warnings and Precautions

Warnings

Do not use to make a child sleepy.

Indications and Usage

Uses

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

■ runny nose

■ itchy, watery eyes

■ sneezing

■ itching of the nose or throat

Dosage and Administration

Directions

Adults and children (12 years and older): 1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age

Description

Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg

Section 50565-1

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

Center (1-800-222-1222) right away.

Section 50567-7

When using this product

■ drowsiness may occur

■ avoid alcoholic beverages

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

Section 51727-6

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

Section 53413-1

Questions or comments? Call 1-800-634-7680

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each tablet)

Chlorpheniramine maleate 4 mg

Section 60561-8

Other information

■ tamper evident sealed packets

■ do not use any opened or torn packets

■ store at 77°F (25°C); excursions permitted between 59º-86ºF (15º-30ºC)

■ protect from excessive moisture

■ use by expiration date on packet

Medique Chlorpen Label

Medique ®

Chlorphen

Allergy and Hay Fever Relief

Alivio a las algergias y la fiebre del heno

Antihistamine • Chlorpheniramine Maleate 4mg

Antihistminico • Maleato de Clorfeniramina 4mg

Pull To Open

Tire Para Abrir

250 Tablets

(250 x 1)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias


Structured Label Content

Indications and Usage (34067-9)

Uses

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

■ runny nose

■ itchy, watery eyes

■ sneezing

■ itching of the nose or throat

Dosage and Administration (34068-7)

Directions

Adults and children (12 years and older): 1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age

Warnings and Precautions (34071-1)

Warnings

Do not use to make a child sleepy.

Section 50565-1 (50565-1)

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

Center (1-800-222-1222) right away.

Section 50567-7 (50567-7)

When using this product

■ drowsiness may occur

■ avoid alcoholic beverages

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

Section 51727-6 (51727-6)

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-634-7680

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Chlorpheniramine maleate 4 mg

Section 60561-8 (60561-8)

Other information

■ tamper evident sealed packets

■ do not use any opened or torn packets

■ store at 77°F (25°C); excursions permitted between 59º-86ºF (15º-30ºC)

■ protect from excessive moisture

■ use by expiration date on packet

Medique Chlorpen Label

Medique ®

Chlorphen

Allergy and Hay Fever Relief

Alivio a las algergias y la fiebre del heno

Antihistamine • Chlorpheniramine Maleate 4mg

Antihistminico • Maleato de Clorfeniramina 4mg

Pull To Open

Tire Para Abrir

250 Tablets

(250 x 1)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias


Advanced Ingredient Data


Raw Label Data

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