Indications and uses
For the relief of the painful symptoms of PMS, including pain, irritability and breast tenderness.
For the relief of the painful symptoms of PMS, including pain, irritability and breast tenderness.
(adults and children 12 years of age and older) Chew two tablets thoroughly, allowing each to dissolve in the mouth, then swallow. Repeat every 4 hours as needed.
| Active Ingredients | Purpose |
| Calcarea carbonica 30C, HPUS | Relieves pain due to cramps |
| Kali-carbonica 30C, HPUS | Relieves breast tenderness |
| Nux vomica 30C, HPUS | Relieves irritability |
| Sepia 30C, HPUS | Relieves irritability and cravings |
"HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.
Statement of Identity: Analgesic.
For the relief of the painful symptoms of PMS, including pain, irritability and breast tenderness.
(adults and children 12 years of age and older)
Chew two tablets thoroughly, allowing each to dissolve in the mouth, then swallow. Repeat every 4 hours as needed.
Lactose, magnesium stearate (vegetable source), stevia leaf extract.
1-888-60-B-WELL (1-888-602-9355)
info@homeostasislabs.com
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 47242-0051-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1701-f424-e053-dadaa90a57ce | PMS RELIEF |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47242-0051-1 | PMS RELIEF | 50 in 1 TUBE | TABLET, CHEWABLE | 50 | 1 | |
| 47242-0051-1 | PMS RELIEF | 1 in 1 PACKAGE | TABLET, CHEWABLE | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 47242-0051 | PMS RELIEF (OYSTER SHELL CALCIUM CARBONATE, CRUDE - POTASSIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - SEPIA OFFICINALIS JUICE -) TABLET, CHEWABLE [HOMEOSTASIS LABORATORIES, INC.] | 1 | Legacy NDC, 2 package rows | 20121116_58b9a493-215d-4d04-8387-eea1e17b889e.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | ACTIVE INGREDIENT | 2E32821G6I | 1 | |
| POTASSIUM CARBONATE | ACTIVE INGREDIENT | BQN1B9B9HA | 1 | |
| SEPIA OFFICINALIS JUICE | ACTIVE INGREDIENT | QDL83WN8C2 | 1 | |
| STRYCHNOS NUX-VOMICA SEED | ACTIVE INGREDIENT | 269XH13919 | 1 | |
| CARBONATE ION | ACTIVE MOIETY | 7UJQ5OPE7D | 1 | |
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | ACTIVE MOIETY | 2E32821G6I | 1 | |
| SEPIA OFFICINALIS JUICE | ACTIVE MOIETY | QDL83WN8C2 | 1 | |
| STRYCHNOS NUX-VOMICA SEED | ACTIVE MOIETY | 269XH13919 | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| STEVIA REBAUDIUNA LEAF | INACTIVE INGREDIENT | 6TC6NN0876 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 47242-0051 | 47242-0051-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 2E32821G6I | ACTIB |
| POTASSIUM CARBONATE | BQN1B9B9HA | ACTIB |
| STRYCHNOS NUX-VOMICA SEED | 269XH13919 | ACTIB |
| SEPIA OFFICINALIS JUICE | QDL83WN8C2 | ACTIB |
| LACTOSE | J2B2A4N98G | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STEVIA REBAUDIUNA LEAF | 6TC6NN0876 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, DELAYED RELEASE / ORAL | 231.84 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, SOLUTION / INTRAVENOUS | 0.45 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / ORAL | 530 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION / INTRAVENOUS | 203.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / RESPIRATORY (INHALATION) | 44.4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, COATED / ORAL | 332.05 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, DELAYED RELEASE / ORAL | 160 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CONCENTRATE / ORAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, COATED PELLETS / ORAL | 135.2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 133 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | SOLUTION / RECTAL | 8 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER, FOR SOLUTION / ORAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 620 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | SUPPOSITORY / VAGINAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | OINTMENT / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | GRANULE, FOR SUSPENSION / ORAL | 512.5 mg/5ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | FILM, EXTENDED RELEASE / TRANSDERMAL | 675 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION / INTRAMUSCULAR | 203.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / ORAL | 2500 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / RECTAL | 20 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / SUBLINGUAL | 352 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, EXTENDED RELEASE / ORAL | 400 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER / RESPIRATORY (INHALATION) | 90 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER / VAGINAL | 430 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CREAM / VAGINAL | 3 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg |
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 |
|---|---|---|---|---|---|---|
| d8e5810e-7619-4e3c-826c-37012cf8ad3a | 58b9a493-215d-4d04-8387-eea1e17b889e | 2012-11-14 | Warnings | d8e5810e-7619-4e3c-826c-37012cf8ad3a 58b9a493-215d-4d04-8387-eea1e17b889e |
Adverse event summaries are temporarily unavailable. Other product information remains available.