Label: SODIUM BICARBONATE ANTACID- sodium bicarbonate tablet
- NDC Code(s): 0536-1046-10
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
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Directions
- do not use the maximum dosage for more than 2 weeks
- tablets may be swallowed whole or dissolved in water prior to use
- adults 60 years of age and over: 2-4 tablets every 4 hours, not more than 24 tablets in 24 hours
- adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours
- Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
WARNING: This product can expose you to chemicals including lead and mercury which are known to the State of
California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.DISTRIBUTED BY:
RUGBY® LABORATORIES
INDIANAPOLIS, IN 46268
Questions or comments?
Call (800) 616-2471
www.majorpharmaceuticals.com
Rev. 10/23 R-29
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE ANTACID
sodium bicarbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1046 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 325 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code CPC76 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1046-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/25/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M001 03/25/2015 Labeler - Rugby Laboratories (079246066)