FDA Label for Sodium Bicarbonate Antacid

View Indications, Usage & Precautions

Sodium Bicarbonate Antacid Product Label

The following document was submitted to the FDA by the labeler of this product Dannso Corp./d.b.a. Essential Products. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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.


Otc - Do Not Use



Do not use in children under 12 years of age.


Ask A Doctor Before Use If You Have



  • a sodium-restricted diet.

Otc - Ask Doctor/Pharmacist



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

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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.
  • 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



  • 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)


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