Label: BICARUVAS- antacid powder, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 69728-0001-1, 69728-0001-2 - Packager: PROSANA DISTRIBUCIONES, S.A. DE C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 10, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Bicaruvas
- Principal Display Please see box.jpg
- Active ingredients
- Uses
- Warnings
- Pregnant
- Overdose
- Inactive
- Other Information
- children
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INGREDIENTS AND APPEARANCE
BICARUVAS
antacid powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69728-0001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TARTARIC ACID (UNII: W4888I119H) (TARTARIC ACID - UNII:W4888I119H) TARTARIC ACID 2 g in 944 mL CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 1 g in 944 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 15 g in 944 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 19 g in 944 mL Inactive Ingredients Ingredient Name Strength GRAPE (UNII: 6X543N684K) 1 g in 944 mL STEVIA LEAF (UNII: 6TC6NN0876) 1 g in 944 mL POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) 1 g in 944 mL Product Characteristics Color Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69728-0001-2 8 in 1 BOX 05/18/2015 1 NDC:69728-0001-1 944 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 04/23/2013 Labeler - PROSANA DISTRIBUCIONES, S.A. DE C.V. (816197867) Establishment Name Address ID/FEI Business Operations PROSANA DISTRIBUCIONES S.A. DE C.V. 816197867 manufacture(69728-0001)