Topcare 44-194

Topcare 44-194
SPL v7
SPL
SPL Set ID 35305aa9-4fc1-4cda-b6f0-89df64f9eeff
Route
ORAL
Published
Effective Date 2026-03-10
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 Aluminum Lake Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: 44;194 Shape: round Color: yellow Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 1992-12-19

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
  • take every 4 to 6 hours, or as directed by a doctor
adults and children 12 years and over 1 tablet. Do not exceed 6 tablets in 24 hours.
children 6 to under 12 years 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
children under 6 years do not use
Do Not Use

to make a child sleepy.

Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) 
  • protect from excessive moisture
  • see end flap for expiration date and lot number
Inactive Ingredients

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

Questions Or Comments?

1-888-423-0139

Principal Display Panel

+TopCare

Health®

NDC 36800-694-08

Allergy Relief

CHLORPHENIRAMINE MALEATE 4 mg - ANTIHISTAMINE

Relieves:

• Sneezing

• Itchy, Watery Eyes

• Runny Nose

• Itchy Throat

4

HOUR

24 TABLETS

actual

size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO LNKA1220 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

50844          ORG041919408

Topcare 44-194
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
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the 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
  • take every 4 to 6 hours, or as directed by a doctor
adults and children 12 years and over 1 tablet. Do not exceed 6 tablets in 24 hours.
children 6 to under 12 years 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
children under 6 years do not use
Do Not Use (Do not use)

to make a child sleepy.

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) 
  • protect from excessive moisture
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Principal Display Panel

+TopCare

Health®

NDC 36800-694-08

Allergy Relief

CHLORPHENIRAMINE MALEATE 4 mg - ANTIHISTAMINE

Relieves:

• Sneezing

• Itchy, Watery Eyes

• Runny Nose

• Itchy Throat

4

HOUR

24 TABLETS

actual

size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO LNKA1220 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

50844          ORG041919408

Topcare 44-194
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)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the 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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