Label: BHI CALMING- matricaria recutita, arabica coffee bean, hops, strychnos ignatii seed, moschus moschiferus musk sac resin, strychnos nux-vomica seed, passiflora incarnata flowering top, sulfur, valerian, and veratrum album root tablet
- NDC Code(s): 62795-1006-2, 62795-1006-3
- Packager: MediNatura 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 August 2, 2023
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- PURPOSE
- USES
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DIRECTIONS
At first sign of symptoms: Adults and children 12 years and older:
1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage.
Standard dosage: Adults and children 12 years and older: Take 1-2 tablets every 4 to 6 hours. Do not exceed 12 tablets in 24 hours.
For children under 12, consult your health professional.
Allow tablets to dissolve completely in the mouth, do not swallow.
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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. Keep out of reach of children. If sleeplessness or nervous tension persist continuously for more than two weeks, a health professional should be consulted. Insomnia may be a symptom of serious underlying medical illness. Do not use if known sensitivity to BHI Calming or any of its ingredients exists
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BHI CALMING
matricaria recutita, arabica coffee bean, hops, strychnos ignatii seed, moschus moschiferus musk sac resin, strychnos nux-vomica seed, passiflora incarnata flowering top, sulfur, valerian, and veratrum album root tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62795-1006 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 2 [hp_X] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 10 [hp_X] HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS 2 [hp_X] STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 8 [hp_X] MOSCHUS MOSCHIFERUS MUSK SAC RESIN (UNII: 8KFK4W7KP7) (MOSCHUS MOSCHIFERUS MUSK SAC RESIN - UNII:8KFK4W7KP7) MOSCHUS MOSCHIFERUS MUSK SAC RESIN 10 [hp_X] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 30 [hp_X] PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 2 [hp_X] VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT 4 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) DEXTROSE (UNII: IY9XDZ35W2) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code Leafman Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62795-1006-3 1 in 1 CARTON 08/30/2014 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:62795-1006-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/30/2014 Labeler - MediNatura Inc (079324099) Establishment Name Address ID/FEI Business Operations MediNatura 102783016 manufacture(62795-1006)