Label: LITTLE COLDS SORE THROAT RELIEF MELT AWAYS- benzocaine granule

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 29, 2009

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  • 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
    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 

  • INGREDIENTS AND APPEARANCE
    LITTLE COLDS SORE THROAT RELIEF MELT AWAYS 
    benzocaine granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 mg
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-102-1212 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35612/31/2009
    Labeler - Medtech Products Inc. (122715688)
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