FDA.reportPublic FDA data

Little Colds Sore Throat Relief Melt Aways

Manufacturer
Medtech Products Inc.
Effective date
2009-12-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:22

Label at a glance#

ProductLittle Colds Sore Throat Relief Melt Aways
Active ingredientBENZOCAINE
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

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

DESCRIPTION SECTION

Benzocaine 6 mg (in each packet)

Purpose

DESCRIPTION SECTION

Oral Anesthetic/Analgesic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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:

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a dentist or doctor if:

OTC - ASK DOCTOR SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.  

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.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

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL 

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043359benzocaine 6 MG Oral GranulesPSN1
1043359benzocaine 6 MG Oral GranulesSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63029-102-122019-10-21C16284748780-1956f9ecf-da3d-621f-e053-dbdaa90a74adLittle Colds Sore Throat Relief Melt Aways

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-102-12Little Colds Sore Throat Relief Melt Aways12 in 1 CARTONGRANULE121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-102LITTLE COLDS SORE THROAT RELIEF MELT AWAYS (BENZOCAINE) GRANULE [MEDTECH PRODUCTS INC.]1Legacy NDC, 1 package rows20100126_6177e21c-65f5-4f53-9ae9-253794431885.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW51
BENZOCAINEACTIVE MOIETYU3RSY48JW51

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-10263029-102-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
225493ba-a97b-42c9-968d-86923f2715dc6177e21c-65f5-4f53-9ae9-2537944318852009-12-29WarningsExact identifier
spl id: 225493ba-a97b-42c9-968d-86923f2715dc
spl set id: 6177e21c-65f5-4f53-9ae9-253794431885

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.