NDC | 43689-0020-1, 43689-0020-2 |
Set ID | 3f62001a-27b5-43cb-8006-110943facf87 |
Category | HUMAN OTC DRUG LABEL |
Packager | The Magni Company |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENTS:
- USES:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
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OTHER INFORMATION:
• Store tightly closed in a cool, dry place (59° - 86°F)
• 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:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
EARACHE RELIEF
belladonna, calcarea carbonica, chamomilla, hepar sulphuris calcareum, kali bichromicum, lycopodium clavatum, plantago major, pulsatilla (vulgaris) tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43689-0020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 12 [hp_X] OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 12 [hp_X] CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 12 [hp_X] LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 12 [hp_X] PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 12 [hp_X] PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS 12 [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:43689-0020-2 1 in 1 PACKAGE 08/24/2016 1 NDC:43689-0020-1 90 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 05/09/2016 Labeler - The Magni Company (113501902) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43689-0020) , api manufacture(43689-0020) , label(43689-0020) , pack(43689-0020)