Label: CALMS NERVE TENSION SLEEPLESSNESS- passiflora incarnata flower, avena sativa leaf, hops, and chamomile tablet
- NDC Code(s): 54973-1120-3
- Packager: Hyland's Inc.
- 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 7, 2022
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- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton
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INGREDIENTS AND APPEARANCE
CALMS NERVE TENSION SLEEPLESSNESS
passiflora incarnata flower, avena sativa leaf, hops, and chamomile tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-1120 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER 1 [hp_X] AVENA SATIVA LEAF (UNII: 206PI19V7R) (AVENA SATIVA LEAF - UNII:206PI19V7R) AVENA SATIVA LEAF 1 [hp_X] HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS 1 [hp_X] CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 2 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) STARCH, TAPIOCA (UNII: 24SC3U704I) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color brown (TAN) Score no score Shape ROUND Size 9mm Flavor Imprint Code HYL;CM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-1120-3 1 in 1 CARTON 01/01/1980 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/1980 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-1120) , pack(54973-1120) , label(54973-1120)