Hst 784 (974)

Hst 784 (974)
SPL v4
SPL
SPL Set ID 92d90b41-0627-121e-e053-2995a90a2df1
Route
ORAL
Published
Effective Date 2018-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;194 Shape: round Color: yellow Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-01

Description

Chlorpheniramine maleate 4 mg 

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Chlorpheniramine maleate 4 mg 

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
Directions

• do not exceed recommended dose

• adults and children 12 years and over: take 1 tablet every 4 to 6 hours,

as needed, not more than 6 tablets in 24 hours or as directed by a doctor

• children under 12: consult a doctor

Do Not Use

to make a child sleepy.

Other Information

• Tamper Evident: Do not use if imprinted seal

under cap is missing or broken. • store at 20-25°C (68-77°F);

excursions permitted between 15°-30°C (59°-86°F)

• protect from moisture

Inactive Ingredients

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

Questions Or Comments?

1-800-540-3765

Principal Display Panel

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
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Chlorpheniramine maleate 4 mg 

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
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

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
Purpose

Antihistamine

Directions

• do not exceed recommended dose

• adults and children 12 years and over: take 1 tablet every 4 to 6 hours,

as needed, not more than 6 tablets in 24 hours or as directed by a doctor

• children under 12: consult a doctor

Do Not Use (Do not use)

to make a child sleepy.

Other Information (Other information)

• Tamper Evident: Do not use if imprinted seal

under cap is missing or broken. • store at 20-25°C (68-77°F);

excursions permitted between 15°-30°C (59°-86°F)

• protect from moisture

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Principal Display Panel (Principal display panel)

When Using This Product (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
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 overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Chlorpheniramine maleate 4 mg 

Ask A Doctor Before Use If You Have (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
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

All Sections (JSON)