allergy relief 4 hour

allergy relief 4 hour
SPL v6
SPL
SPL Set ID 4d974959-25fc-4707-9b72-9afbf47b76f1
Route
oral
Published
Effective Date 2017-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chlorpheniramine (4 mg)
Inactive Ingredients
d&c yellow no. 10 lactose, unspecified form magnesium stearate microcrystalline cellulose stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: AZ;246 Shape: round Color: yellow Size: 8 mm Score: 1
Marketing Status
otc monograph drug active Since 2014-12-15

Purpose

Antihistamine

Description

Chlorpheniramine maleate 4mg


Medication Information

Active Ingredient

Chlorpheniramine maleate 4mg

Uses

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

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat
Purpose

Antihistamine

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: ½ 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
Other Information
  • store between 20°-25°C (68°-77°F)
  • do not use if seal under cap is broken or missing
Inactive Ingredients

D&C yellow #10 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid

Description

Chlorpheniramine maleate 4mg

Principal Display Panel
Allergy Relief
Questions Or Comments?

1-888-952-0050 (Monday-Friday 9AM-5PM EST)

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 or operating machinery
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

 In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Chlorpheniramine maleate 4mg

Uses

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

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat
Purpose

Antihistamine

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: ½ 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
Other Information (Other information)
  • store between 20°-25°C (68°-77°F)
  • do not use if seal under cap is broken or missing
Inactive Ingredients (Inactive ingredients)

D&C yellow #10 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid

Principal Display Panel
Allergy Relief
Questions Or Comments? (Questions or Comments?)

1-888-952-0050 (Monday-Friday 9AM-5PM EST)

When Using This Product (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 or operating machinery
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

 In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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