SODIUM BICARBONATE ANTACID- sodium bicarbonate powder 
Dannso Corp./d.b.a. Essential Products

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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SODIUM BICARBONATE ANTACID

Drug Facts

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

Sodium bicarbonate USP 2,616 mg

Purpose

Antacid

Uses

Relieves:

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

AgeMaximum Dosage
Adults 60 years and overDo not exceed three doses of 1/2 teaspoon in a 24 hour period.
Adults and children 12 years and overDo not exceed six doses of 1/2 teaspoon in a 24 hour period.
Children under 12 yearsDo not use.

Do not exceed recommended dosage. See warnings.

Other information

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)

PRINCIPAL DISPLAY PANEL - 113 g Bottle Label
SODIUM BICARBONATE ANTACID 
sodium bicarbonate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70242-131
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE2.6 g  in 2.6 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70242-131-04113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/08/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33109/25/2013
Labeler - Dannso Corp./d.b.a. Essential Products (059741071)
Registrant - Dannso Corp./d.b.a. Essential Products (059741071)
Establishment
NameAddressID/FEIBusiness Operations
Dannso Corp./d.b.a. Essential Products059741071LABEL(70242-131)
Establishment
NameAddressID/FEIBusiness Operations
World Perfume, Inc101312044MANUFACTURE(70242-131)

Revised: 1/2016
Document Id: 17197886-8f32-41a8-afa9-6f2c53a83bd1
Set id: 79702bcd-65c4-4265-8139-93d93e983e75
Version: 1
Effective Time: 20160101
 
Dannso Corp./d.b.a. Essential Products