Only For

Only For
SPL v2
SPL
SPL Set ID 796150ee-d59b-4af2-ad10-d82c083807ea
Route
ORAL
Published
Effective Date 2019-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg)
Inactive Ingredients
D&c Yellow No. 10 Anhydrous Lactose Magnesium Palmitostearate Microcrystalline Cellulose 101 Starch, Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-03-29

Description

Chlorpheniramine Maleate 4mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Chlorpheniramine Maleate 4mg

Uses:
  • 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
Section 42229-5

NDC: 73006-113-41

ANTIHISTAMINE

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Tear along perforation push product through foil

Packaging

Warnings:

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

Do not take if

you are taking sedatives or tranquilizers

When using this product

  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
Do not use to make a child sleepy

If pregnant or breast-feeding,

ask a health professional before use.

Drug Facts

Directions:
  • take with a full glass of water
  • Do not take more than directed
 adults and children 12 years 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  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 at room temperature between 20-25°C (68-77°F).
  • protect from excessive heat and moisture
Inactive Ingredients:

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

Questions Or Comments ?

1-833-665-9444.

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.

Active Ingredient (in Each Tablet)

Chlorpheniramine Maleate 4mg


Structured Label Content

Uses:
  • 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
Section 42229-5 (42229-5)

NDC: 73006-113-41

ANTIHISTAMINE

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Tear along perforation push product through foil

Purpose

Antihistamine

Packaging

Warnings:

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

Do not take if

you are taking sedatives or tranquilizers

When using this product

  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
Do not use to make a child sleepy

If pregnant or breast-feeding,

ask a health professional before use.

Drug Facts (DRUG FACTS)

Directions:
  • take with a full glass of water
  • Do not take more than directed
 adults and children 12 years 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  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 at room temperature between 20-25°C (68-77°F).
  • protect from excessive heat and moisture
Inactive Ingredients:

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

Questions Or Comments ? (QUESTIONS OR COMMENTS ?)

1-833-665-9444.

Keep Out of Reach of Children (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.

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

Chlorpheniramine Maleate 4mg


Advanced Ingredient Data


Raw Label Data

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