SPL v6
SPL
SPL Set ID 3e5d245f-515c-4106-a855-fb97681b646a
Route
ORAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Dextrose Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Maltitol Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-04

Description

Guaifenesin, USP 100 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin, USP 100 mg

Uses
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Warnings

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

Ask a doctor before use if the child has:

  • cough that occurs with too much phlegm (mucus)
  • persistant or chronic cough such as occurs with asthma.
Directions
  • do not use more than 6 doses in any 24-hour period
 age  dose
 Children 6 years to under 12 years  1 - 2 teaspoonfuls every 4 hours
 Children 4 years to under 6 years  1/2 - 1 teaspoonful every 4 hours
 Children under 4 years  do not use

Drug Facts

Guaifenesin, USP 100 mg

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Other Information
  • each 5 mL teaspoon contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F)
  • do not refrigerate
  • dosing cup provided
  • Keep carton for full Directions for use.
Inactive Ingredients

Anhydrous citric acid, dextrose, FD and C Blue # 1, FD and C Red # 40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum

Stop Use and As A Doctor If
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistant headache. These could be signs of a serious illness
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.

Discount Drug Mart Food Fair Childrens Chest Congestion Relief Grape

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S MUCINEX® CHEST CONGESTION

DISCOUNT

drug

mart

FOOD FAIR

Children's Chest Congestion Relief

Guaifenesin Oral Solution, USP

EXPECTORANT

Relieves Chest Congestion

Thins & Loosens Mucus

Alcohol-Free

For Ages 4 to 12

Grape Flavor

4 FL OZ (118 mL)

* This product is not manufactured or distributed by Reckitt Benckiser, Inc., distributer of Children's Mucinex®

SATISFACTION GUARANTEED

IF DISSASIFIED , RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

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Structured Label Content

Uses
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Purpose

Expectorant

Warnings

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

Ask a doctor before use if the child has:

  • cough that occurs with too much phlegm (mucus)
  • persistant or chronic cough such as occurs with asthma.
Directions
  • do not use more than 6 doses in any 24-hour period
 age  dose
 Children 6 years to under 12 years  1 - 2 teaspoonfuls every 4 hours
 Children 4 years to under 6 years  1/2 - 1 teaspoonful every 4 hours
 Children under 4 years  do not use

Drug Facts

Guaifenesin, USP 100 mg

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Other Information (Other information)
  • each 5 mL teaspoon contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F)
  • do not refrigerate
  • dosing cup provided
  • Keep carton for full Directions for use.
Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, dextrose, FD and C Blue # 1, FD and C Red # 40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum

Stop Use and As A Doctor If (Stop use and as a doctor if)
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistant headache. These could be signs of a serious illness
Keep Out of Reach of Children (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.

Discount Drug Mart Food Fair Childrens Chest Congestion Relief Grape (DISCOUNT drug mart FOOD FAIR Childrens Chest Congestion Relief - Grape)

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S MUCINEX® CHEST CONGESTION

DISCOUNT

drug

mart

FOOD FAIR

Children's Chest Congestion Relief

Guaifenesin Oral Solution, USP

EXPECTORANT

Relieves Chest Congestion

Thins & Loosens Mucus

Alcohol-Free

For Ages 4 to 12

Grape Flavor

4 FL OZ (118 mL)

* This product is not manufactured or distributed by Reckitt Benckiser, Inc., distributer of Children's Mucinex®

SATISFACTION GUARANTEED

IF DISSASIFIED , RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

res


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