Your browser does not support JavaScript! SMART SENSE CHILDRENS MUCUS RELIEF (GUAIFENESIN) LIQUID [KMART CORPORATION]
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SMART SENSE CHILDRENS MUCUS RELIEF (guaifenesin) liquid
[Kmart Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredient (in each 5 mL)

Guaifenesin, USP 100 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

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

store at 20-25°C (68º-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, FD&C blue # 1, FD&C red # 40, flavor, glycerin, maltitol solution propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient of Children’s Mucinex® Chest Congestion

CHILDREN'S

MUCUS RELIEF

Expectorant - Guaifenesin

Relieves Chest Congestion

Thins and Loosens Mucus

For Ages 4 to 12

Alcohol Free

GLUTEN FREE

Non-Drowsy

Grape FLAVOR LIQUID

Dosage Cup Included

Children's Mucus Relief Carton Image 1
Children's Mucus Relief Carton Image 2
SMART SENSE CHILDRENS MUCUS RELIEF 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-288
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
ColorPURPLE (clear) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49738-288-261 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/03/2010
Labeler - Kmart Corporation (008965873)

Revised: 01/2013
Document Id: 82a51671-6d78-4b50-9164-bd34ada16fdb
Set id: c72c92a7-90a2-49e3-8555-644247c6a542
Version: 2
Effective Time: 20130117
 
Kmart Corporation

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