Allergy - Alergia (chlorpheniramine Maleate 4mg)

Allergy - Alergia (chlorpheniramine Maleate 4mg)
SPL v2
SPL
SPL Set ID 91d2ec38-7ea2-2b3a-e053-2a95a90af3fd
Route
ORAL
Published
Effective Date 2018-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: S72 Shape: round Color: yellow Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-12-20

Description

Chlorpheniramine Maleate 4mg


Medication Information

Warnings and Precautions

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostrate gland

Ask a doctor or a pharmacist before use if

you sre taking sedatives or tranquilzers

When using this product

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

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Indications and Usage

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
Dosage and Administration
  • take with a full glass of water
  • do not take more than directed
adults and children 12 yers of age and over 1 tablet every 4 to 6 hours, do not take more than 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 ask a doctor

Description

Chlorpheniramine Maleate 4mg

Section 50565-1

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

D&C yellow #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch

Section 51945-4

Section 55105-1

Antihistamine

Section 55106-9

Chlorpheniramine Maleate 4mg

Section 60561-8
  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
  • protect from excessive heat and moisture

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)
  • take with a full glass of water
  • do not take more than directed
adults and children 12 yers of age and over 1 tablet every 4 to 6 hours, do not take more than 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 ask a doctor

Warnings and Precautions (34071-1)

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostrate gland

Ask a doctor or a pharmacist before use if

you sre taking sedatives or tranquilzers

When using this product

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

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

D&C yellow #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Chlorpheniramine Maleate 4mg

Section 60561-8 (60561-8)
  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
  • protect from excessive heat and moisture

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)