Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 6a1a5cef-e946-4ba8-9402-557c6adf45f9
Route
ORAL
Published
Effective Date 2019-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Yellow No. 10 Calcium Phosphate, Dibasic, Anhydrous Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: PH012 Shape: round Color: yellow Size: 8 mm Score: 1
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 following symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Section 51945-4

PHARBEST

NDC 73057-346-11

Manufactured in the USA

4 Hour Allergy Relief

*Compare to the active ingredient in Chlor-Trimeton ®

Pharbechlor

CHLORPHENIRAMINE MALEATE 4 MG - ANTIHISTAMINE

For Temporary relief of:

•Itchy,Watery Eyes  •Runny Nose

•Itchy Throat          •Sneezing

1000 Tablets

Directions
adults and children 12 years 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  1/2 tablet (break tablet in half) every 4 to 6 hours. Do not to exceed 3 whole tablets in 24 hours.
children under 6 years  ask a doctor

Do Not Use

to make a child sleepy.

Other Information
  • store at 20-25 oC (68-77 oF)
Inactive Ingredients

corn starch, croscarmellose sodium, D&C yellow # 10, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product
  • drowsiness may occur
  • avoid alcoholic drinks
  • 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 (1-800-222-1222).

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 following symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Section 51945-4 (51945-4)

PHARBEST

NDC 73057-346-11

Manufactured in the USA

4 Hour Allergy Relief

*Compare to the active ingredient in Chlor-Trimeton ®

Pharbechlor

CHLORPHENIRAMINE MALEATE 4 MG - ANTIHISTAMINE

For Temporary relief of:

•Itchy,Watery Eyes  •Runny Nose

•Itchy Throat          •Sneezing

1000 Tablets

Purpose

Antihistamine

Directions
adults and children 12 years 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  1/2 tablet (break tablet in half) every 4 to 6 hours. Do not to exceed 3 whole tablets in 24 hours.
children under 6 years  ask a doctor

Do Not Use (Do not use)

to make a child sleepy.

Other Information (Other information)
  • store at 20-25 oC (68-77 oF)
Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, D&C yellow # 10, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product (When using this product)
  • drowsiness may occur
  • avoid alcoholic drinks
  • 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 (1-800-222-1222).

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

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