LITTLE COLDS SORE THROAT RELIEF MELT AWAYS- benzocaine granule

Little Colds Sore Throat Relief Melt Aways by

Drug Labeling and Warnings

Little Colds Sore Throat Relief 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 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

• Empty entire contents of packet onto tongue, allow to dissolve, then swallow
  
• For best taste, do not chew granules

• Age: Dose
• under 3 years: Consult a doctor
• 3 to under 6 years: 1 packet every 2 hours as needed
• 6 years and over: 1 – 2 packets every 2 hours as needed

Other Information

• Store at 59–77°F (15–25°C).
  
• Tamper Evident: Do not use if foil packets are broken.
  
• Check expiration date before using.

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

• Relives Pain
  
• Soothes Throat
  
• No measuring, no mixing,
  no worries – just relief!

Great tasting

GRAPE flavor

12 - 6 mg Benzocaine granule packets

 

INGREDIENTS AND APPEARANCE

LITTLE COLDS SORE THROAT RELIEF MELT AWAYS 
benzocaine granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	6 mg

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-102-12	12 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part356	12/31/2009

Labeler - Medtech Products Inc. (122715688)