Label: LITTLE REMEDIES SORE THROAT POPS- pectin lozenge

  • NDC Code(s): 63029-406-10, 63029-406-20
  • Packager: Medtech Products Inc.
  • 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 January 1, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each Pop)

    Pectin 5.4 mg

  • Purpose

    Oral demulcent

  • Uses

    For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

  • Warnings

    Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious.

    Stop use and ask a doctor if

    • sore mouth does not improve in 7 days

    • irritation, pain or redness persists or worsens

    Keep out of reach of children

  • Directions

    • adults and children 3 years of age and older: allow one pop to dissolve slowly in mouth

    • May be repeated as needed or as directed by a doctor

    • Children under 3 years of age: ask a doctor

  • Other information

    Store at 20°-25°C (68°-77°F) in a dry place

  • Inactive ingredients

    caramel color, corn syrup, honey, natural flavor, sucrose, water

  • Questions? 1-800-754-8853 

    Mon.-Fri. 8 am to 8 pm EST

    LittleRemedies.com

  • PRINCIPAL DISPLAY PANEL

    Little Remedies
    Sore Throat Pops
    Pectin /Oral Demulcent
    10 Pops

    PRINCIPAL DISPLAY PANEL Little Remedies Sore Throat Pops Pectin /Oral Demulcent 10 Pops

  • INGREDIENTS AND APPEARANCE
    LITTLE REMEDIES  SORE THROAT POPS
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-406
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN5.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    HONEY (UNII: Y9H1V576FH)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOW (honey color) Scoreno score
    ShapeROUNDSize20mm
    FlavorHONEYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-406-1010 in 1 CARTON; Type 0: Not a Combination Product06/01/2015
    2NDC:63029-406-2020 in 1 BAG; Type 0: Not a Combination Product06/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35606/01/2015
    Labeler - Medtech Products Inc. (122715688)
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