Little Remedies Little Colds Mucus Relief Expectorant Melt Aways
FDA Label NDC 63029-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Little Remedies Little Colds Mucus Relief Expectorant Melt Aways (NDC 63029-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, use, ask a doctor before use if you have:, stop use and ask a doctor if:, when using this product:, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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
    • 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

  • 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

    Principal Display Panel (Little Colds Mucus Relief Melt Aways 02)

    Principal Display Panel (Little Colds Mucus Relief Melt Aways 02)

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