NDC | 62795-1024-2 |
Set ID | 894e79d9-beed-4dcc-8f07-7745e798daef |
Category | HUMAN OTC DRUG LABEL |
Packager | MediNatura Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- KEEP OUT OF REACH OF CHILDREN
- Uses
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WARNINGS
Do not give to children under 12 years of age.If pregnant or breast-feeding, ask a health professional before use. If sleeplessness or nervous tension persists continuously for more than two weeks, a health professional should be consulted. Insomnia may be a symptom of serious underlying medical illness. Due to the homeopathic nature of WellMind Calming, a temporary worsening in symptoms (initial aggravation) may occur, but often resolves quickly. Allergic (hypersensitivity) skin reactions may occur in very rare casses. Do not use if known sensitivity to Wellmind Calming or any of its ingredients exists.
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DIRECTIONS
At first sign of symptoms: Adults and children 12 years and older: 1 tablet every ½ to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours. For children under 12 years, consult your health professional.
Standard dosage: Adults and children 12 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours. For children under 12 years, consult your health professional.
Allow tablets to dissolve completely in the mouth, do not swallow.
- PURPOSE
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ACTIVE INGREDIENTS
Active Ingredients Purpose
*Avena sativa 2X.........................Relieves simple nervous tension
*Coffea cruda 12X.......................Relieves irritability
*Passiflora incarnata3X................Relieves simple nervous tension
*Sepia 4X...................................Relieves occasional nervous sleeplessness
*Valeriana officinalis 2X................Relieves occasional nervous sleeplessness
*Valeriana officinalis 10X..............Relieves occasional nervous sleeplessness
*Valeriana officinalis 30X.............Relieves occasional nervous sleeplessness
*NaturalIngredients
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WELLMIND CALMING
avena sativa flowering top, arabica coffee bean, passiflora incarnata flowering top,sepia officinalis juice, and valerian tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62795-1024 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 2 [hp_X] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 12 [hp_X] PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X] SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 4 [hp_X] VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 2 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code mountain Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62795-1024-2 1 in 1 CARTON 08/30/2014 07/30/2025 1 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/30/2014 07/30/2025 Labeler - MediNatura Inc (079324099) Establishment Name Address ID/FEI Business Operations MediNatura Inc 102783016 manufacture(62795-1024)