Indications and uses
Uses*: Homeopathic remedy for tantrums in young children * Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Tula Tantrum Tamer
- Manufacturer
- Silver Star Brands | OHM Pharma, Inc.
- Effective date
- 2025-01-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:29:59
Label at a glance#
ProductTula Tantrum Tamer
Active ingredientARTEMISIA CINA FLOWER, MATRICARIA RECUTITA
Label structure10 sections
Dosage and administration
Directions For all ages: Take 5 pilules 2 times daily. Alternatively, for small babies, crush pilules onto tongue.
Label contents#
Full prescribing information#
HPUS Active Ingredients
HPUS Active Ingredients: Equal parts of each ingredient in a 6C potency: Chamomilla, Cina.
Uses*
Uses*: Homeopathic remedy for tantrums in young children
* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings
Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Directions For all ages: Take 5 pilules 2 times daily. Alternatively, for small babies, crush pilules onto tongue.
OTHER SAFETY INFORMATION
Contains no artificial flavors or colorants. No gluten added. Lactose-free.
Tamper resistant for your protection. Use only if safetey seal is in tact.
Inactive Ingredients
Inactive Ingredients: Organic Sucrose
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep this and all medication out of reach of children.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding, ask a health professional before use.
OTC - PURPOSE SECTION
Reduces restlessness & tantrums in children
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68703-365-20 | 2023-12-25 | C162847 | 48780-1 | f386c649-ab1a-0266-e053-dadaa90a7c1a | NativeRemedies® Tula Tantrum Tamer™ Granules |
| 68703-365-20 | 2023-01-30 | C162847 | 48780-1 | f386c649-ab1a-0266-e053-dadaa90a7c1a | NativeRemedies® Tula Tantrum Tamer™ Granules |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68703-365-20 | Tula Tantrum Tamer | 26 g in 1 BOTTLE, GLASS | PELLET | 26 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Tula Tantrum Tamer
- Chamomilla, Cina
- SUCROSE
- ARTEMISIA CINA FLOWER
- MATRICARIA RECUTITA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68703-365 | 68703-365-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| ARTEMISIA CINA FLOWER | 28M1820ACT | ACTIB |
| MATRICARIA RECUTITA | G0R4UBI2ZZ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Tula Tantrum Tamer | CHAMOMILLA, CINA | Silver Star Brands | bc2bd616-272f-94d0-e053-2a95a90a598e | 2025-01-01 | Warnings | 68703-365-20 68703-365 68703036520 2ab10b12-68eb-3af8-e063-6294a90af21f bc2bd616-272f-94d0-e053-2a95a90a598e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.