Bicaruvas (Antacid) Powder, For Solution [Prosana Distribuciones, S.a. De C.v.] -

BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]
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NDC	69728-0002-1
Set ID	2033ba7b-9989-24ef-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	PROSANA DISTRIBUCIONES, S.A. DE C.V.
Generic Name
Product Class	Anti-coagulant
Product Number
Application Number	PART331

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69728-0002-1	118 mL in 1 PACKET; Type 0: Not a Combination Product	09/20/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	04/23/2013

Labeler - PROSANA DISTRIBUCIONES, S.A. DE C.V. (816197867)

Name	Address	ID/FEI	Business Operations
Establishment
PROSANA DISTRIBUCIONES S.A. DE C.V.		816197867	manufacture(69728-0002)

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