Label: SODIUM BICARBONATE ANTACID- sodium bicarbonate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 70242-131-04 - Packager: Dannso Corp./d.b.a. Essential Products
- 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 1, 2016
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each dose = 1/2 teaspoon)
- Purpose
- Uses
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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.
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
- 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
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- PRINCIPAL DISPLAY PANEL - 113 g Bottle Label
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INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE ANTACID
sodium bicarbonate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70242-131 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:70242-131-04 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/08/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part331 09/25/2013 Labeler - Dannso Corp./d.b.a. Essential Products (059741071) Registrant - Dannso Corp./d.b.a. Essential Products (059741071) Establishment Name Address ID/FEI Business Operations Dannso Corp./d.b.a. Essential Products 059741071 LABEL(70242-131) Establishment Name Address ID/FEI Business Operations World Perfume, Inc 101312044 MANUFACTURE(70242-131)