Label: SMOKE FREE- dieffenbachia seguine, daphne odora bark, graphites, valerian tablet
- NDC Code(s): 68466-0598-1
- Packager: Schwabe Mexico, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 22, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- INACTIVE INGREDIENT
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Dosage & Administration:
Directions: Sublingual medication. Place tablet under tongue and let dissolve.
Tablets work best when taken at least 15 minutes before or after eating, brushing your teeth, or drinking anything except water.
Adults: Stop smoking completely.
Weeks 1 through 3, 1 tablet every hour.
Weeks 4 through 6, 1 tablet every 2 hours, or as needed.
Weeks 7 through 9, 1 tablet 4 times a day, or as needed.
- Indications and Usage
- Purpose
- Warning
- Pregnancy or Breast Feeding
- Keep Out of Reach of Children
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SMOKE FREE
dieffenbachia seguine, daphne odora bark, graphites, valerian tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68466-0598 Route of Administration SUBLINGUAL, SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE 6 [hp_X] DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D) DAPHNE ODORA BARK 12 [hp_X] GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 12 [hp_X] VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 6 [hp_X] Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (B;T) Score no score Shape ROUND (BT) Size 8mm Flavor Imprint Code B;T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68466-0598-1 1 in 1 BOX 06/01/2017 12/30/2025 1 100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/01/2017 12/30/2025 Labeler - Schwabe Mexico, S.A. de C.V. (812805901) Establishment Name Address ID/FEI Business Operations Schwabe Mexico, S.A. de C.V. 812805901 manufacture(68466-0598)