Label: TINY TOT COUGH SYRUP- squilla, antimonium tart, arsenicum alb, belladonna, bryonia, chamomilla, cuprum met, drosera, hepar sulph calc, ipecacuanha, kali bic, kali carb, phosphorus, pulsatilla, spongia syrup

  • NDC Code(s): 43406-0595-4
  • Packager: Natural Creations, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 21, 2018

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS - equal amounts of: Squilla 8X, Antimonium Tart 30C, Arsenicum Alb 30C, Belladonna 30C, Bryonia 30C, Chamomilla 30C, Cuprum Met 30C, Drosera 30C, Hepar Sulph Calc 30C, Ipecacuanha 30C, Kali Bic 30C, Kali Carb 30C, Phosphorus 30C, Pulsatilla 30C, Spongia 30C

  • INDICATIONS & USAGE

    USES: Temporarily relieves cough (dry cough, tickling cough, hacking cough).**

  • PURPOSE

    USES: Temporarily relieves cough (dry cough, tickling cough, hacking cough).**

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Age 0-6 years: 1/2 teaspoon up to 8 times per day. 6 years and older: 1 teaspoon up to 8 times per day.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

  • WARNINGS

    WARNINGS:

    • Consult a physician for use in children under 12 years of age.
    • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
    • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
    • A persistent cough may be a sign of a more serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied be fever, rash, or persistent headache, consult a doctor.
    • Do not use if TAMPER EVIDENT seal is broken or missing.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Acacia Gum, Citric Acid, Glycerin USP, Grape Flavor, Grape Skin Extract, Potassium Sorbate, Purified Water

  • QUESTIONS

    QUESTIONS & COMMENTS?

    Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

  • REFERENCES

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • PRINCIPAL DISPLAY PANEL

    NDC:43406-0595-4

    Tiny Tot Cough Syrup

    HOMEOPATHIC

    4 fl oz (120mL)

    image description

  • INGREDIENTS AND APPEARANCE
    TINY TOT COUGH SYRUP 
    squilla, antimonium tart, arsenicum alb, belladonna, bryonia, chamomilla, cuprum met, drosera, hepar sulph calc, ipecacuanha, kali bic, kali carb, phosphorus, pulsatilla, spongia syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0595
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DRIMIA MARITIMA BULB (UNII: 3629601H5D) (DRIMIA MARITIMA BULB - UNII:3629601H5D) DRIMIA MARITIMA BULB8 [hp_X]  in 1 mL
    ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE30 [hp_C]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE30 [hp_C]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT30 [hp_C]  in 1 mL
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE30 [hp_C]  in 1 mL
    copper (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) copper30 [hp_C]  in 1 mL
    DROSERA ROTUNDIFOLIA WHOLE (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA WHOLE30 [hp_C]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE30 [hp_C]  in 1 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC30 [hp_C]  in 1 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE30 [hp_C]  in 1 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE30 [hp_C]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_C]  in 1 mL
    PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE30 [hp_C]  in 1 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    VITIS VINIFERA ANTHOCYANINS (UNII: F02KPB2508)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0595-4120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/11/2015
    Labeler - Natural Creations, Inc (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc030572478manufacture(43406-0595)
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