Label: DE LA CRUZ DESEMPACHO- sodium bicarbonate liquid
- NDC Code(s): 24286-1523-4
- 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 January 26, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 15 mL=1 tablespoon)
- Purpose
- Uses
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Warnings
Do not use
- this product when abdominal pain, nausea, vomiting or other symptoms of appendicitis are present
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
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Directions
- shake well before using
- adults and children 12 years of age and older: one tablespoonful (15 mL) every four hours as needed or as directed by a doctor. Do not take more than 6 tablespoons in 24 hours.
- consult a doctor for use in children under 12 years of age
- do not exceed recommended dosage. See Warnings.
- Other information
- Inactive ingredients
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
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INGREDIENTS AND APPEARANCE
DE LA CRUZ DESEMPACHO
sodium bicarbonate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1523 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 525 mg in 15 mL Inactive Ingredients Ingredient Name Strength PEPPERMINT (UNII: V95R5KMY2B) WATER (UNII: 059QF0KO0R) RHUBARB (UNII: G280W4MW6E) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24286-1523-4 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/15/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 03/15/2016 Labeler - DLC LABORATORIES, INC. (093351930) Establishment Name Address ID/FEI Business Operations DLC Laboratories, Inc. 093351930 manufacture(24286-1523) , label(24286-1523)