Kmart Corporation Children's Mucus Relief Cough Drug Facts

Smart Sense Mucus Relief Cough by

Drug Labeling and Warnings

Smart Sense Mucus Relief Cough by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SMART SENSE MUCUS RELIEF COUGH CHILDRENS- dextromethorphan hydrobromide, guaifenesin solution 
Kmart Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Kmart Corporation Children's Mucus Relief Cough Drug Facts

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Purpose

Cough suppressant

Expectorant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves:
• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
• the intensity of coughing
• the impulse to cough to help your child get to sleep

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.

Ask a doctor before use if the child has

• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with asthma

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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).

Directions

• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• do not use dosing cup with other products
• mL = milliliter

• Age:

  Dose

• children 6 years to under 12 years:

  5 mL - 10 mL every 4 hours

• children 4 years to under 6 years:

  2.5 mL – 5 mL every 4 hours

• children under 4 years:

  do not use

Other information

• do not use if printed neckband is broken or missing
• store at 20-25°C (68-77°F)
• do not refrigerate
• dosing cup provided

Inactive ingredients

acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO ACTIVE INGREDIENTS IN CHILDREN’S MUCINEX® COUGH

FOR AGES 4-12 YEARS

children’s

mucus relief cough

GUAIFENESIN 100 mg

DEXTROMETHORPHAN HBR 5 mg

EXPECTORANT

COUGH SUPPRESSANT

CHERRY FLAVOR

ALCOHOL FREE

RELIEVES

CHEST CONGESTION & COUGH

THINS & LOOSENS MUCUS

4 FL OZ (118 mL)

SMART SENSE MUCUS RELIEF COUGH  CHILDRENS
dextromethorphan hydrobromide, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-419
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED (Dark Red)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-419-26	1 in 1 CARTON	12/09/2010	07/23/2018
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/09/2010	07/23/2018

Labeler - Kmart Corporation (008965873)

Revised: 12/2019

Document Id: 7ab28657-b33f-4268-a6b8-072267153fde

34390-5

Set id: 26b58f9c-f138-4369-9708-09c36d88a7d6

Version: 5

Effective Time: 20191217

 

Kmart Corporation