SODIUM BICARBONATE ANTACID- sodium bicarbonate powder

SODIUM BICARBONATE ANTACID by

Drug Labeling and Warnings

SODIUM BICARBONATE ANTACID by is a Otc medication manufactured, distributed, or labeled by Dannso Corp./d.b.a. Essential Products, World Perfume, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose = 1/2 teaspoon)

Sodium bicarbonate USP 2,616 mg

Purpose

Antacid

Uses

Relieves:

• heartburn
• sour stomach
• acid indigestion
• upset stomach associated with these symptoms

Warnings

FOR ORAL USE ONLY

Do not use if Tamper Evident Seal is missing or broken.

STOMACH WARNING

TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL POWDER IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK.

Do not use in children under 12 years of age.

Ask a doctor before use if you have

• a sodium-restricted diet.

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

• you have used the maximum dosage for 2 weeks
• severe stomach pain occurs after using this product

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center immediately.

Directions

• take ½ level teaspoon in ½ glass (4 fl. oz.) of water every 2 hours up to maximum dosage or as directed by a doctor. Dissolve completely in water before drinking.

Age	Maximum Dosage
Adults 60 years and over	Do not exceed three doses of 1/2 teaspoon in a 24 hour period.
Adults and children 12 years and over	Do not exceed six doses of 1/2 teaspoon in a 24 hour period.
Children under 12 years	Do not use.

Do not exceed recommended dosage. See warnings.

Other information

• each 1/2 teaspoon dose contains: sodium 716 mg

Questions or Comments

Distributed by

Essential Products Miami FL 33126

www.essentialproductsuse.com

Made in U.S.A.

Questions

1-800-858-3889

PRINCIPAL DISPLAY PANEL - 113 g Bottle Label

De La Cruz®

Sodium
Bicarbonate
USP
- Oral Powder -

Antacid

NET WT 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE ANTACID 
sodium bicarbonate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70242-131
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	2.6 g  in 2.6 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70242-131-04	113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/08/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part331	09/25/2013

Labeler - Dannso Corp./d.b.a. Essential Products (059741071)

Registrant - Dannso Corp./d.b.a. Essential Products (059741071)

Establishment
Name	Address	ID/FEI	Business Operations
Dannso Corp./d.b.a. Essential Products		059741071	LABEL(70242-131)

Establishment
Name	Address	ID/FEI	Business Operations
World Perfume, Inc		101312044	MANUFACTURE(70242-131)