242r Chlor Mal

242r Chlor Mal
SPL v2
SPL
SPL Set ID 588c424a-8dd6-417e-8f76-2ce0cc2b0c12
Route
ORAL
Published
Effective Date 2011-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg)
Inactive Ingredients
Anhydrous Lactose Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Magnesium Stearate Cellulose, Microcrystalline Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: TCL242 Shape: round Color: yellow Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-02-08

Description

Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg


Medication Information

Warnings and Precautions

Warnings

Ask a doctor before use if you have:

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

Indications and Usage

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

runny nose, sneezing, itching of the nose or throat, itch, watery eyes

Dosage and Administration

Directions

Adults and children 12 years and over - 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours

Children 6 to under 12 years of age - 1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours

Children under 6 years of age - do not use

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 right away.
Section 50567-7

When using this product:

excitability may occur, especially in children; drowsiness may occur; avoid alcoholic beverages; alcohol, sedatives and tranquilizers may increase drowsiness; use caution when driving a motor vehicle operating machinery

Section 50568-5
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Section 51727-6
anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.
Section 51945-4

Section 53414-9
If 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


Structured Label Content

Indications and Usage (34067-9)

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

runny nose, sneezing, itching of the nose or throat, itch, watery eyes

Dosage and Administration (34068-7)

Directions

Adults and children 12 years and over - 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours

Children 6 to under 12 years of age - 1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours

Children under 6 years of age - do not use

Warnings and Precautions (34071-1)

Warnings

Ask a doctor before use if you have:

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

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 right away.
Section 50567-7 (50567-7)

When using this product:

excitability may occur, especially in children; drowsiness may occur; avoid alcoholic beverages; alcohol, sedatives and tranquilizers may increase drowsiness; use caution when driving a motor vehicle operating machinery

Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Section 51727-6 (51727-6)
anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.
Section 51945-4 (51945-4)

Section 53414-9 (53414-9)
If 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


Advanced Ingredient Data


Raw Label Data

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