Dosage and administration
Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.
Coumarin
- Manufacturer
- Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC
- Effective date
- 2026-01-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:50:00
Label at a glance#
ProductCoumarin 1513
Active ingredientCOUMARIN
Label structure9 sections
Label contents#
Full prescribing information#
ACTIVE INGREDIENTS
Coumarin 9X, 12X, 30X, 60X
QUESTIONS
Professional Formulas
PO Box 2034 Lake Oswego, OR 97035
INDICATIONS
For the temporary relief of bloating, gas, fatigue, occasional headache, hay fever, or minor lower back or neck pain due to sensitivity to phenolic compounds found in foods or other products.*
OTC - PURPOSE SECTION
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
WARNINGS
In case of overdose, get medical help or contact a poison control center right away.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding, ask a healthcare professional before use.
DIRECTIONS
Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.
OTHER INFORMATION
Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.
INACTIVE INGREDIENTS
20% ethanol, purified water.
LABEL
Est 1985
Professional Formulas
Complementary Health
Coumarin
Homeopathic Remedy
1 FL. OZ. (29.5 mL)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63083-1513-1 | 2026-01-09 | C162847 | 48780-1 | 1030e365-113b-111a-e063-dadaa90a10e2 | YCOU |
| 63083-1513-1 | 2026-01-09 | C162847 | 48780-1 | 1030e365-113b-111a-e063-dadaa90a10e2 | YCOU |
| 63083-1513-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-113b-111a-e063-dadaa90a10e2 | YCOU |
| 63083-1513-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-113b-111a-e063-dadaa90a10e2 | YCOU |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63083-1513-1 | Coumarin1513 | 29.5 mL in 1 BOTTLE, DROPPER | LIQUID | 29.5 | 2 |
Products#
Every source-derived product name is available through these pages.
- Coumarin 1513
- Coumarin
- ALCOHOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63083-1513 | 63083-1513-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| COUMARIN | A4VZ22K1WT | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2019-08-15 | full-release | 2026-06-01 02:17:01 |
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 |
|---|---|---|---|---|---|---|
| Coumarin 1513 | COUMARIN | Professional Complementary Health Formulas | 4eb6aaf9-428d-4c5c-afe9-9bc4ccfac9bc | 2026-01-08 | Warnings | 63083-1513-1 63083-1513 63083151301 a286b63f-f94f-4621-a992-3b306ef1d4e1 4eb6aaf9-428d-4c5c-afe9-9bc4ccfac9bc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.