Tiny Tot Cough Syrup
- Manufacturer
- Natural Creations, Inc | OHM Pharma, Inc
- Effective date
- 2025-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:36:06
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
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 SECTION
USES: Temporarily relieves cough (dry cough, tickling cough, hacking cough).**
OTC - PURPOSE SECTION
USES: Temporarily relieves cough (dry cough, tickling cough, hacking cough).**
DOSAGE & ADMINISTRATION SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 SECTION
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 SECTION
INACTIVE INGREDIENTS: Acacia Gum, Citric Acid, Glycerin USP, Grape Flavor, Grape Skin Extract, Potassium Sorbate, Purified Water
OTC - QUESTIONS SECTION
QUESTIONS & COMMENTS?
Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600
REFERENCES SECTION
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC:43406-0595-4
Tiny Tot Cough Syrup
HOMEOPATHIC
4 fl oz (120mL)
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0877730002877 | GTIN-13: 0877730002877 EAN-13: 0877730002877 GTIN-12: 877730002877 UPC-A: 877730002877 GTIN storage (14 digits): 00877730002877 | Tiny Tot Cough Syrup.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c599c4a0-705d-4ebb-ab1f-977af038f96a | Product name | 1 | 20251124 |
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43406-0595-4 | Tiny Tot Cough Syrup | 120 mL in 1 BOTTLE, PLASTIC | SYRUP | 120 | 2 |
Products#
Every source-derived product name is available through these pages.
- 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
- DRIMIA MARITIMA BULB
- ANTIMONY POTASSIUM TARTRATE
- ANTIMONY CATION (3+)
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- ATROPA BELLADONNA
- BRYONIA ALBA ROOT
- MATRICARIA CHAMOMILLA WHOLE
- MATRICARIA CHAMOMILLA
- copper
- DROSERA ROTUNDIFOLIA WHOLE
- DROSERA ROTUNDIFOLIA
- CALCIUM SULFIDE
- IPECAC
- POTASSIUM DICHROMATE
- DICHROMATE ION
- POTASSIUM CARBONATE
- CARBONATE ION
- PHOSPHORUS
- PULSATILLA VULGARIS WHOLE
- ANEMONE PULSATILLA
- SPONGIA OFFICINALIS SKELETON, ROASTED
- ACACIA
- CITRIC ACID MONOHYDRATE
- GLYCERIN
- VITIS VINIFERA ANTHOCYANINS
- POTASSIUM SORBATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43406-0595 | 43406-0595-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | Natural Creations, Inc | 38cc6bfc-c59f-4df1-9cff-10b3673b475a | 2025-12-18 | Warnings | 43406-0595-4 43406-0595 43406059504 4d02524a-6662-4e3e-8b6d-d7b16cbdaca4 38cc6bfc-c59f-4df1-9cff-10b3673b475a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
