Little Colds Sore Throat Relief Melt Aways
FDA Label NDC 63029-102

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 Colds Sore Throat Relief Melt Aways (NDC 63029-102). 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, warnings, when using this product:, stop use and ask a dentist or doctor if:, if pregnant or breast-feeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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
    • 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

  • 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

    Principal Display Panel (Little Colds Sore Throat Relief Melt Aways 02)

    Principal Display Panel (Little Colds Sore Throat Relief Melt Aways 02)

     

* Please review the disclaimer below.