Label: DE LA CRUZ SODIUM BICARBONATE ANTACID- sodium bicarbonate powder
- NDC Code(s): 24286-1537-7, 24286-1537-8
- 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.
Updated August 5, 2019
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each dose = 1/2 teaspoon)
FOR ORAL USE ONLY
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.
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
- 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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 113 g Bottle Label
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 2 NDC:24286-1537-8 226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/2019 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)