Label: SLEEP ASSIST- chamomilla, coffea cruda, avena sativa, nux vomica, passiflora incarnata tablet, orally disintegrating
- NDC Code(s): 43689-0018-1, 43689-0018-2
- Packager: The Magni Company
- Category: HUMAN OTC DRUG LABEL
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 June 19, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- PURPOSE:
- USES:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
-
OTHER INFORMATION:
Store tightly closed in a dry place
• Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing
• The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United
States
• These statements are supported by the traditional homeopathic principles
- INACTIVE INGREDIENT
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
SLEEP ASSIST
chamomilla, coffea cruda, avena sativa, nux vomica, passiflora incarnata tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43689-0018 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 4 [hp_X] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 4 [hp_X] AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 6 [hp_X] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 6 [hp_X] PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 6 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape ROUND (Convex) Size 6mm Flavor Imprint Code ML Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43689-0018-2 1 in 1 CARTON 06/19/2023 1 NDC:43689-0018-1 125 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 06/19/2023 Labeler - The Magni Company (113501902) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43689-0018) , api manufacture(43689-0018) , label(43689-0018) , pack(43689-0018)