Children's Cough Mucus Relief 512

Children's Cough Mucus Relief 512
SPL v2
SPL
SPL Set ID 2c27aca4-e1e2-419a-84c4-857718ca49da
Route
ORAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Dextrose D&c Red No. 33 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 2016-08-04

Description

Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 mg

Uses
  • temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes
Warnings

Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions , or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. if you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Directions
  • do not take more than 6 doses in any 24-hour period

age                                                                   dose

Children 6 years to 12 years                               1 to 2 teaspoonfuls (tsps) every 4 hours

Children 4 years to under 6 years                        1/2 to 1 teaspoonful (tsps) every 4 hours

Children under 4 years                                         do not use

Drug Facts

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

Questions?

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

Other Information
  • each teaspoonful contains sodium 3 mg
  • store between20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
  • Keep carton for full direction for use
Inactive Ingredients

anhydrous citric acid, dextrose, D&C red #33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum

When Using This Product
  • do not use more than directed
Stop Use and Ask 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 condition.

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

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
Children's Cough Mucus Relief Product Label

DISCOUNT

drug

mart

FOOD FAIR

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

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S MUCINEX® COUGH*

Children's Cough Mucus Relief

Cough Suppressent

Expectorant

Dextromethorphan HBr 5 mg

Guaifensin 100 mg

Relieves Chest Congestion

Thins & Loosens Mucus

Alcohol free

for ages 4 to 12

CHERRY FLAVOR

4 FL OX (118 ml)

* this product is not manufactured or distributed by Reckitt Benckiser Inc., the distributer of Childrens Mucinex® Cough.

SATISFACTION GUARANTEED

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

BX-052

res


Structured Label Content

Uses
  • temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes
Purpose

Cough suppressant

Expectorant

Warnings

Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions , or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. if you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Directions
  • do not take more than 6 doses in any 24-hour period

age                                                                   dose

Children 6 years to 12 years                               1 to 2 teaspoonfuls (tsps) every 4 hours

Children 4 years to under 6 years                        1/2 to 1 teaspoonful (tsps) every 4 hours

Children under 4 years                                         do not use

Drug Facts

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

Questions?

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

Other Information (Other information)
  • each teaspoonful contains sodium 3 mg
  • store between20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
  • Keep carton for full direction for use
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, dextrose, D&C red #33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (Stop use and ask 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 condition.

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

Ask A Doctor Before Use If the Child Has (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
Children's Cough Mucus Relief Product Label (Children's Cough Mucus Relief product label)

DISCOUNT

drug

mart

FOOD FAIR

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

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S MUCINEX® COUGH*

Children's Cough Mucus Relief

Cough Suppressent

Expectorant

Dextromethorphan HBr 5 mg

Guaifensin 100 mg

Relieves Chest Congestion

Thins & Loosens Mucus

Alcohol free

for ages 4 to 12

CHERRY FLAVOR

4 FL OX (118 ml)

* this product is not manufactured or distributed by Reckitt Benckiser Inc., the distributer of Childrens Mucinex® Cough.

SATISFACTION GUARANTEED

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

BX-052

res


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