FDA.reportPublic FDA data

Little Remedies Little Colds Mucus Relief Expectorant Melt Aways

Manufacturer
Medtech Products Inc.
Effective date
2009-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:10

Label at a glance#

ProductLittle Remedies Little Colds Mucus Relief Expectorant Melt Aways
Active ingredientGUAIFENESIN
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 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

Label contents#

Full prescribing information#

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

DESCRIPTION SECTION

Guaifenesin 100 mg (in each packet)

Purpose

DESCRIPTION SECTION

Expectorant

Use

INDICATIONS & USAGE SECTION

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Ask a doctor before use if you have:

SPL UNCLASSIFIED SECTION

  • 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:

OTC - STOP USE SECTION

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:

OTC - WHEN USING SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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
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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

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

LC13101

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
647407guaiFENesin 100 MG Oral GranulesPSN1
1539995Little Colds Mucus Relief Melt Aways 100 MGPSN1
1539995guaifenesin 100 MG Oral Granules [Little Colds Mucus Relief]SBD1
647407guaifenesin 100 MG Oral GranulesSCD1
1539995Little Colds Mucus Relief 100 MG Oral GranulesSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63029-101-122019-10-21C16284748780-1956f9ecf-d81b-621f-e053-dbdaa90a74adLittle Colds Mucus Relief Melt Aways

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-101-12Little Remedies Little Colds Mucus Relief Expectorant Melt Aways12 in 1 CARTONGRANULE121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-101LITTLE REMEDIES LITTLE COLDS MUCUS RELIEF EXPECTORANT MELT AWAYS (GUAIFENESIN) GRANULE [MEDTECH PRODUCTS INC.]1Legacy NDC, 1 package rows20100101_cb0b60f1-b6ae-4c55-841e-136b8898a930.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
GUAIFENESINACTIVE MOIETY495W7451VQ1

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
63029-10163029-101-12

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
GUAIFENESIN495W7451VQACTIB

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
cbac2426-7be1-4f95-888d-a1501871f284cb0b60f1-b6ae-4c55-841e-136b8898a9302009-12-18WarningsExact identifier
spl id: cbac2426-7be1-4f95-888d-a1501871f284
spl set id: cb0b60f1-b6ae-4c55-841e-136b8898a930

Reported adverse events (FAERS/openFDA)#

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