BICARUVAS- antacid powder, for solution 
PROSANA DISTRIBUCIONES, S.A. DE C.V.

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.

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Bicaruvas Double Action Antacid

Bicaruvas

Double Action

BICARUVAS

.Sodium Bicarbonate

.Calcium Carbonate

Antiacid

Effervescent Powder

8 packets .17 oz (5g) ea. Front

Directions

.Adult and children 12 years older dissolve one packet in 1/2 glass of water every 4 hours or as directed by your doctor.

Children under 12 years, consult a doctor Dosage

Principal Display
Please see box.jpg

Outer label

Active ingredients

Active Ingredients (in each packet) Purpose

Sodium Bicarbonate 2.452g antacid

Citric Acid 1.927 g antiacid

Tartaric Acid 0.220g antiacid

Calcium Carbonate .05 g antiacid

Active Ingredients

Uses

Uses for the relief of:

Heartburn . Sour stomach . upset stomach associated with these symptoms

uses

Warnings

Warnings Do not exceed more than 5 packets in a 24 hour period

Do not exceed more than 3 packets in 24 hours if you are 60 years or older

the maximum dosage for more than two weeks except under the advise and supervision of a physician

Warnings

Pregnant

If pregnant or breat feeding, ask a helth professional before use pregnant

Overdose

In case of Overdose get medical help or contact a Poison Control Center right away.

Inactive

Inactive Ingredients

grape flavor. stevia. polyethilene glycol 4000

Other Information

Other Information

each packet contains 671 mg of sodium

each packet contains 20 mg of calcium

store in a dry cool place

children

Keep out of reach of children children

BICARUVAS 
antacid powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69728-0001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TARTARIC ACID (UNII: W4888I119H) (TARTARIC ACID - UNII:W4888I119H) TARTARIC ACID2 g  in 944 mL
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION1 g  in 944 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID15 g  in 944 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE19 g  in 944 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69728-0001-28 in 1 BOX05/18/2015
1NDC:69728-0001-1944 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/23/2013
Labeler - PROSANA DISTRIBUCIONES, S.A. DE C.V. (816197867)
Establishment
NameAddressID/FEIBusiness Operations
PROSANA DISTRIBUCIONES S.A. DE C.V.816197867manufacture(69728-0001)

Revised: 6/2015
Document Id: 11ac9e26-dd8c-5321-e054-00144ff8d46c
Set id: 19c65683-788e-6f71-e054-00144ff8d46c
Version: 4
Effective Time: 20150610
 
PROSANA DISTRIBUCIONES, S.A. DE C.V.