Storage and handling
SHAKE WELL
AM-5
- Manufacturer
- DNA Labs, Inc.
- Effective date
- 2025-01-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:30:12
Label at a glance#
ProductAM-5
Active ingredientHELLEBORUS NIGER WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, BOS TAURUS BILE
Label structure7 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
NDC 58264-0344-1
INDICATIONS
OTC - PURPOSE SECTION
Regulates energy flow in the large intestine meridian.
INGREDIENTS
INACTIVE INGREDIENT SECTION
Helleborus niger 8x, Magnesia phosphorica 8x, Fel tauri 12x, aa partes, 20% alcohol in purified water.
SUGGESTED DOSAGE
5 to 10 drops twice a day, meridian energy excess 1 to 5 drops t.i.d, meridian lacking in energy 10 to 20 drops t.i.d.
STORAGE AND HANDLING SECTION
SHAKE WELL
Warnings
SPL UNCLASSIFIED SECTION
- Use only if cap seal is unbroken.
OTC - PREGNANCY OR BREAST FEEDING SECTION
- As with drugs if you are pregnant or nursing a baby seek professional advice before using this product.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- Keep this and all medication out of the reach of children.
SPL UNCLASSIFIED SECTION
To be used according to standard homeopathic indications.
PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label
DYNAMIC
NUTRITIONAL
ASSOCIATES, INC.
AM-5
LARGE INTESTINE
ACUPUNCTURE MERIDIAN
1 FL. OZ.
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58264-0344-1 | 2022-06-02 | C162847 | 48780-1 | 9d75b9d0-94ed-f424-e053-dadaa90a57ce | AM-5 |
| 58264-0344-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-94ed-f424-e053-dadaa90a57ce | AM-5 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58264-0344-1 | AM-5 | 29.57 mL in 1 BOTTLE, GLASS | SOLUTION | 29.57 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58264-0344 | AM-5 (HELLEBORUS NIGER WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, AND BOS TAURUS BILE) SOLUTION [DNA LABS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250112_0d4b5527-cc14-4dd0-84d9-b403e281f1fe.zip |
Products#
Every source-derived product name is available through these pages.
- AM-5
- HELLEBORUS NIGER WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and BOS TAURUS BILE
- ALCOHOL
- WATER
- HELLEBORUS NIGER WHOLE
- MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
- MAGNESIUM CATION
- BOS TAURUS BILE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58264-0344 | 58264-0344-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| HELLEBORUS NIGER WHOLE | H0NO2VNJ61 | ACTIB |
| MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE | HF539G9L3Q | ACTIB |
| BOS TAURUS BILE | ET3651ZLOU | 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 |
|---|---|---|---|---|---|---|
| AM-5 | HELLEBORUS NIGER WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, AND BOS TAURUS BILE | DNA Labs, Inc. | 0d4b5527-cc14-4dd0-84d9-b403e281f1fe | 2025-01-09 | Warnings | 58264-0344-1 58264-0344 58264034401 2b52dd9d-5dee-a801-e063-6294a90aeffa 0d4b5527-cc14-4dd0-84d9-b403e281f1fe |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.