Label: LEG AND BACK PAIN RELIEF- capsicum annuum, colocynthis, gnaphalium polycephalum, magnesia phosphorica tablet
- NDC Code(s): 43689-0013-1, 43689-0013-2
- Packager: The Magni Company
- 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 September 14, 2020
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- ACTIVE INGREDIENTS:
- USES:
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WARNINGS:
• If pregnant or breastfeeding, ask a health professional before use
• Keep out of reach of children, Do not take this product for pain for more than 7 days unless directed by a doctor. If pain persists or gets worse, if new symptoms occur, or redness or swelling is present, consult a doctor because these could be signs of a serious condition.
• In case of overdose, get medical help or contact a Poison Control Center right away
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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
- DIRECTIONS:
- INACTIVE INGREDIENTS:
- KEEP OUT OF REACH OF CHILDREN:
- INDICATIONS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
LEG AND BACK PAIN RELIEF
capsicum annuum, colocynthis, gnaphalium polycephalum, magnesia phosphorica tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43689-0013 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 6 [hp_X] CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 6 [hp_X] PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM 6 [hp_X] MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (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:43689-0013-2 1 in 1 CARTON 06/11/2015 1 NDC:43689-0013-1 125 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 06/11/2015 Labeler - The Magni Company (113501902) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43689-0013) , api manufacture(43689-0013) , label(43689-0013) , pack(43689-0013)
