Label: DE LA CRUZ SODIUM BICARBONATE ANTACID- sodium bicarbonate powder

  • NDC Code(s): 24286-1537-7
  • Packager: DLC Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 12, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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

    Sodium bicarbonate USP 2,616 mg

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  • Purpose

    Antacid

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  • Uses

    relieves:

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

    FOR ORAL USE ONLY

    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.

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  • 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.

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  • Other information

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

    Distributed by:
    De La Cruz Products
    A Division of DLC Laboratories, Inc.
    Paramount, CA 90723 USA

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  • Questions

    1-800-858-3889

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  • 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
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  • INGREDIENTS AND APPEARANCE
    DE LA CRUZ SODIUM BICARBONATE ANTACID 
    sodium bicarbonate powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1537
    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:24286-1537-7 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/25/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part331 09/25/2013
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    Name Address ID/FEI Business Operations
    DLC Laboratories, Inc. 093351930 REPACK(24286-1537) , LABEL(24286-1537) , MANUFACTURE(24286-1537)
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