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
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
- INDICATIONS & USAGE
- PURPOSE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
-
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
- QUESTIONS
- REFERENCES
- PRINCIPAL DISPLAY PANEL
-
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 syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0595 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DRIMIA MARITIMA BULB (UNII: 3629601H5D) (DRIMIA MARITIMA BULB - UNII:3629601H5D) DRIMIA MARITIMA BULB 8 [hp_X] in 1 mL ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE 30 [hp_C] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 30 [hp_C] in 1 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 30 [hp_C] in 1 mL MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 30 [hp_C] in 1 mL copper (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) copper 30 [hp_C] in 1 mL DROSERA ROTUNDIFOLIA WHOLE (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA WHOLE 30 [hp_C] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 30 [hp_C] in 1 mL IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 30 [hp_C] in 1 mL POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 30 [hp_C] in 1 mL POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 30 [hp_C] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_C] in 1 mL PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE 30 [hp_C] in 1 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor grape Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43406-0595-4 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/11/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/11/2015 Labeler - Natural Creations, Inc (018022074) Establishment Name Address ID/FEI Business Operations OHM Pharma, Inc 030572478 manufacture(43406-0595)