Label: ROLFIA- crataegus oxy, passiflore inc, rauwolfia ser, kali brom tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69825-007-01, 69825-007-02 - Packager: Adven Biotech Private Limited
- 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 April 1, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- Warnings:
- PURPOSE
- Uses:
- INACTIVE INGREDIENT
- DO NOT USE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROLFIA
crataegus oxy, passiflore inc, rauwolfia ser, kali brom tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69825-007 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 3 [hp_X] in 100 g CRATAEGUS MONOGYNA LEAF (UNII: A2KER9748T) (CRATAEGUS MONOGYNA LEAF - UNII:A2KER9748T) CRATAEGUS MONOGYNA LEAF 2 [hp_X] in 100 g PASSIFLORA INCARNATA ROOT (UNII: 3952I8DXEX) (PASSIFLORA INCARNATA ROOT - UNII:3952I8DXEX) PASSIFLORA INCARNATA ROOT 2 [hp_X] in 100 g RAUWOLFIA SERPENTINA (UNII: H192N84N1G) (RAUWOLFIA SERPENTINA - UNII:H192N84N1G) RAUWOLFIA SERPENTINA 2 [hp_X] in 100 g Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) Product Characteristics Color white Score no score Shape ROUND Size 6mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69825-007-02 1 in 1 BOX 03/30/2016 1 NDC:69825-007-01 100 g 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 03/30/2016 Labeler - Adven Biotech Private Limited (858029164) Establishment Name Address ID/FEI Business Operations Adven Biotech Private Limited 858029164 manufacture(69825-007) , relabel(69825-007) , repack(69825-007)
