BRIOSCHI EFFERVESCENT ANTACID- sodium bicarbonate and tartaric acid granule, effervescent
Brioschi Pharmaceuticals International, LLC

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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Brioschi Effervescent Antacid

Drug Facts

Active Ingredients (in each dose)

Sodium Bicarbonate 1.80 grams
Tartaric Acid 1.62 grams

Purpose

Sodium Bicarbonate.............Antacid
Tartaric Acid..........................Antacid

Uses

Provides relief of •heartburn •acid indigestion •upset stomach associated with above conditions.

Warnings

Do not exceed recomended dosage.

Do not use this product if you are on a sodium restricted diet, unless directed by a physician.

Do not take more than the recommended daily dosage (see Directions) in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice & supervision of a physician.

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if symptoms last for more than 2 weeks.

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

Directions

Fully disolve one capful (approx. 6 grams) in a 4-6 ounces of water before drinking.

Adults and children 12 Years and older	One dose each hour	Do not exceed 6 doses in 24 hours
Adults 60 years and older	One dose each hour	Do not exceed 3 doses in 24 hours
Children under 12	Ask a doctor

Other Information

Each 6 gram dose contains 500 mg of sodium. BRIOSCHI Efferescent antacid in water contains the antacid Sodium Tartrate as the principal active ingredient. Store in a cool dry place. Reseal cap tightly.

Inactive Ingredients

Sugar, Corn Syrup, Natural Lemon Flavor.

Questions or comments?

1800-BRIOSCHI or www.brioschi.com

PRINCIPAL DISPLAY PANEL

ASPIRIN-FREE

ALL-NATURAL

FAST ACTING

Say Bree-os-kee

Brioschi ®

Effervescent Antacid

For Fast Relief of Heartburn, Acid Indigestion, or Upset Stomach

FAST ACTING • PLEASANT TASTING • NATURAL LEMON FLAVOR

NET WEIGHT 4-1/4 OZ (120 GRAMS)

BRIOSCHI PHARMACEUTICALS
INTERNATIONAL LLC., SYRACUSE, NY USA 13208

ASPIRIN-FREE

ALL-NATURAL

FAST ACTING

Say Bree-os-kee

Brioschi ®

Effervescent Antacid

For Fast Relief of Heartburn, Acid Indigestion, or Upset Stomach

FAST ACTING • PLEASANT TASTING • NATURAL LEMON FLAVOR

NET WEIGHT 8-1/2 OZ (240 GRAMS)

BRIOSCHI PHARMACEUTICALS
INTERNATIONAL LLC., SYRACUSE, NY USA 13208

BRIOSCHI EFFERVESCENT ANTACID
sodium bicarbonate, tartaric acid granule, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52567-001
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	1.8 g in 6 g
TARTARIC ACID (UNII: W4888I119H) (TARTARIC ACID - UNII:W4888I119H)	TARTARIC ACID	1.63 g in 6 g

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)
CORN SYRUP (UNII: 9G5L16BK6N)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	LEMON (Natural Lemon Flavor)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52567-001-01	240 g in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2010	03/25/2016
2	NDC:52567-001-02	120 g in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2010	03/25/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	09/20/2010	03/25/2016

Labeler - Brioschi Pharmaceuticals International, LLC (001663038)

Revised: 3/2016

Document Id: 2ee45897-58a8-6772-e054-00144ff88e88

Set id: d5fa213b-e6eb-0de2-136c-0c2b9af1aa8b

Version: 2

Effective Time: 20160325

Brioschi Pharmaceuticals International, LLC