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

Tiny Tot Cough Syrup by

Drug Labeling and Warnings

Tiny Tot Cough Syrup by is a Homeopathic medication manufactured, distributed, or labeled by Natural Creations, Inc, OHM Pharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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 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)