ChildrensRelief Expectorant Grape

Dosage form: liquid
Ingredients: GUAIFENESIN 100mg in 5mL
Labeler: Food Lion
NDC Code: 55316-157

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.

Drug Facts

Active Ingredients

Guaifenesin, USP 100 mg

Purpose

Guaifenesin, USP.....................Expectorant

Uses

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

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 or chronic bronchitis

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 illness.

When using this product

• do not use more than directed

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional
assistance or contact a Poison Control Center
immediately.

Directions

• do not exceed 6 doses in a 24-hour period

age                                                                 dose
children 6 years to under 12 years            1-2 teaspoonfuls (tsps) every 4 hours
children 4 years to under 6 years              1/2-1 teaspoonful (tsp) every 4 hours
children under 4 years                                do not use

Other Information

each teaspoon contains: sodium 3 mg
• store at controlled room temperature
• dosage cup provided

Inactive Ingredients

blue 1, citric acid anhydrous, dextrose, flavor,
glycerin, methyl paraben, potassium sorbate,
propylene glycol, propyl paraben, purified water,
red 40, saccharin sodium, sodium hydroxide,
sucralose, xanthan gum

Principal Display Panel

Healthy Accents

Childrens Mucus Relief Expectorant

Relieves

Chest Congestion

Thins and Loosens Mucus

Alcohol-Free

For Ages 4 to 12

Grape Flavor

*Compare to active ingredient in Childrens Mucinex

4 FL OZ (118 mL)

CHILDRENSRELIEF EXPECTORANT GRAPE 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-157
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
ANHYDROUS CITRIC ACID 
DEXTROSE 
GLYCERIN 
METHYLPARABEN 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
FD&C RED NO. 40 
SACCHARIN SODIUM ANHYDROUS 
SODIUM HYDROXIDE 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55316-157-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/23/2009
Labeler - Food Lion (090322194)
Registrant - Aaron Industries, Inc. (101896231)
Establishment
NameAddressID/FEIOperations
Aaron Industries, Inc.101896231manufacture, analysis

Revised: 11/2009
 
Food Lion

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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