LITTLE COLDS SORE THROAT RELIEF MELT AWAYS- benzocaine 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.

----------

Little Colds Sore Throat Relief Melt Aways

Brand: Little Remedies

Product Name: Little Colds Sore Throat Melt Aways

Size: 12 packets

Country: USA

Artwork Description: IFC

Artwork #: LC14101

Active ingredients

Benzocaine 6 mg (in each packet)

Purpose

Oral Anesthetic/Analgesic

Use

For the temporary relief of occasional minor irritation, pain, sore throat, and sore mouth.

Warnings

Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under (3) years of age unless directed by a doctor.

When using this product:

do not exceed recommended dosage.

Stop use and ask a dentist or doctor if:

sore mouth symptoms do not improve in 7 days; irritation, pain or redness persists or worsens; swelling, rash or fever develops.  

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 3 yearsConsult a doctor
3 to under 6 years1 packet every 2 hours as needed
6 years and over1 – 2 packets every 2 hours as needed

Other Information

Inactive Ingredients

cocoa butter, crospovidone, flavor, glucose, hypromellose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sucralose, sucrose, talc

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

LC14101

PRINCIPAL DISPLAY PANEL

MEDICATED FOR KIDS 3+

LITTLE

Colds® 

By Little

Remedies

NEW!

SORE

THROAT

RELIEF

Melt Aways

Benzocaine – Oral Anesthetic / Analgesic

Great tasting

GRAPE flavor

12 - 6 mg Benzocaine granule packets

PRINCIPAL DISPLAY PANEL 

LITTLE COLDS SORE THROAT RELIEF MELT AWAYS 
benzocaine granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 mg
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-102-1212 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35612/31/2009
Labeler - Medtech Products Inc. (122715688)

Revised: 12/2009
Document Id: 225493ba-a97b-42c9-968d-86923f2715dc
Set id: 6177e21c-65f5-4f53-9ae9-253794431885
Version: 1
Effective Time: 20091229
 
Medtech Products Inc.