LITTLE REMEDIES LITTLE COLDS MUCUS RELIEF EXPECTORANT MELT AWAYS- guaifenesin granule 
Medtech Products Inc.

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.

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Little Colds Mucus Relief Melt Aways

Brand: Little Remedies

Product Name: Little Colds Mucus Relief Melt Aways

Size: 12 packets 

Country: USA

Artwork Description: IFC

Artwork #: LC13101

Active ingredients

Guaifenesin 100 mg (in each packet)

Purpose

Expectorant

Use

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 you have:

  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Cough that occurs with too much phlegm (mucus)

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 exceed recommended dosage.

If pregnant or breast-feeding

Ask a health care professional before use.  

Keep out of reach of children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

Directions

AgeDose
Under 4 yearsDo not use
4 – under 6 years1 packet every 4 hours
6 to under 12 years 1 – 2 packets every 4 hours
12 years and over 2 – 4 packets every 4 hours

Other Information

Inactive Ingredients

cellulose, cocoa butter, crospovidone, flavor, glucose, hydrogenated vegetable oil, hydroxypropyl methylcellulose, mannitol, methacrylic acid, polyethylene glycol, polysorbate 80, povidone, silicon dioxide, sodium lauryl sulfate, starch, sucralose, sucrose, talc, triethyl citrate

Questions

 For further information you may contact us at: 1-800-7-LITTLE, or visit us at www.LittleRemedies.com.

©2009 Dist. by Medtech Products Inc.

Irvington, NY 10533

A Prestige Brands Company

LC13101

PRINCIPAL DISPLAY PANEL

MEDICATED FOR KIDS 2+

LITTLE

Colds® 

By Little

Remedies

NEW!

MUCUS

RELIEF

Melt Aways

Guaifenesin Expectorant

Great tasting

BUBBLE GUM flavor

12 - 100 mg guaifenesin granule packets

PRINCIPAL DISPLAY PANEL

LITTLE REMEDIES LITTLE COLDS MUCUS RELIEF EXPECTORANT MELT AWAYS 
guaifenesin granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-101-1212 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35612/31/2009
Labeler - Medtech Products Inc. (122715688)

Revised: 12/2009
Document Id: cbac2426-7be1-4f95-888d-a1501871f284
Set id: cb0b60f1-b6ae-4c55-841e-136b8898a930
Version: 1
Effective Time: 20091218
 
Medtech Products Inc.