Label: SUNDOWN HONEY SOOTHERS LOLLIPOPS- pectin lozenge

  • 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 28, 2018

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  • Active Ingredient

    In each Lollipop:

    Pectin 5.4 mg..............................................................Oral demulcent

  • Uses

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

  • Uses

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

  • Directions

    ■ Adults and children 4 years of age and older: Allow product to
    dissolve slowly in mouth. May be repeated as needed or as directed
    by a doctor.
    ■ Children under 4 years of age: Consult a doctor.

  • 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.
    Discontinue use and consult a doctor if:
    ■ sore mouth does not improve in 7 days
    ■ irritation, pain or redness persists or worsens
    Keep out of reach of children

  • 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.

  • Discontinue use and consult 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 4 years of age and older: Allow product to
    dissolve slowly in mouth. May be repeated as needed or as directed
    by a doctor.
    ■ Children under 4 years of age: Consult a doctor.

  • Inactive ingredients

    Citric acid, evaporated cane sugar, natural flavor, organic honey,
    organic rice syrup, sodium citrate, sucrose, water

  • Questions?

    Call 1-888-VITAHELP (848-2435)

  • PRINCIPAL DISPLAY PANEL

    Orange flavor

  • PRINCIPAL DISPLAY PANEL

    Raspberry flavor

  • INGREDIENTS AND APPEARANCE
    SUNDOWN HONEY SOOTHERS LOLLIPOPS 
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24737-1902
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554) 40 g  in 100 g
    WATER (UNII: 059QF0KO0R) 50 g  in 100 g
    HONEY (UNII: Y9H1V576FH) 9 g  in 100 g
    Product Characteristics
    ColororangeScorescore with uneven pieces
    ShapeROUND (Lollipop) Size50mm
    FlavorRASPBERRY (Honey Raspberry) , ORANGE (Honey Orange) Imprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24737-1902-260 g in 1 CARTON; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/01/2019
    Labeler - The Nature's Bounty Company (052790318)
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