LITTLE REMEDIES LITTLE COLDS MUCUS RELIEF EXPECTORANT MELT AWAYS- guaifenesin granule

Little Remedies Little Colds Mucus Relief Expectorant Melt Aways by

Drug Labeling and Warnings

Little Remedies Little Colds Mucus Relief Expectorant Melt Aways by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• Empty entire contents of packet onto tongue, allow to dissolve, then swallow
  
• For best taste, do not chew granules
  
• Do not take more than 6 doses in any 24-hour period

• Age: Dose
• Under 4 years: Do not use
• 4 – under 6 years: 1 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

• Store at 59–77°F (15–25°C).
  
• Tamper Evident: Do not use if package has been disturbed or opened.
  
• Check expiration date before using.

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

• Relives Chest Congestion
  
• Thins and Loosens Mucus
  
• No measuring, no mixing,
  no worries – just relief!

Great tasting

BUBBLE GUM flavor

12 - 100 mg guaifenesin granule packets

INGREDIENTS AND APPEARANCE

LITTLE REMEDIES LITTLE COLDS MUCUS RELIEF EXPECTORANT MELT AWAYS 
guaifenesin granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-101-12	12 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	12/31/2009

Labeler - Medtech Products Inc. (122715688)