BICARUVAS- antacid powder, for solution

BICARUVAS by

Drug Labeling and Warnings

BICARUVAS by is a Otc medication manufactured, distributed, or labeled by PROSANA DISTRIBUCIONES, S.A. DE C.V., PROSANA DISTRIBUCIONES S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Bicaruvas

Double Action

BICARUVAS

.Sodium Bicarbonate

.Calcium Carbonate

Antiacid

Effervescent Powder

8 packets .17 oz (5g) ea.

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

Principal Display Please see box.jpg

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

Uses

Uses for the relief of:

Heartburn . Sour stomach . upset stomach associated with these symptoms

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

Pregnant

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

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

INGREDIENTS AND APPEARANCE

BICARUVAS 
antacid powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69728-0002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TARTARIC ACID (UNII: W4888I119H) (TARTARIC ACID - UNII:W4888I119H)	TARTARIC ACID	220 mg  in 118 mL
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	50 mg  in 118 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	1827 mg  in 118 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	2452 mg  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
GRAPE (UNII: 6X543N684K)	150 mg  in 118 mL
STEVIA LEAF (UNII: 6TC6NN0876)	50 mg  in 118 mL
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)	150 mg  in 118 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: 69728-0002-1	118 mL in 1 PACKET; Type 0: Not a Combination Product	09/20/2015

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(69728-0002)