Label: SODIUM BICARBONATE 5 GR (325 MG)- sodium bicarbonate tablet
- NDC Code(s): 70369-002-01
- Packager: CitraGen Pharmaceuticals 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 September 5, 2019
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- Drug Facts
Do not take more than 48 tablets for adults up to 60 years of age (or 24 tablets for adults 60 years of age and older) in a 24-hour period nor use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
- 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?
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
CitraGen Pharmaceuticals, Inc.,
Fremont, CA 94538.
Rev. 03/18 R-00
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE 5 GR (325 MG)
sodium bicarbonate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70369-002 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 HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color white Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code CG002 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70369-002-01 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 04/20/2018 Labeler - CitraGen Pharmaceuticals Inc. (024949457) Registrant - CitraGen Pharmaceuticals Inc. (024949457) Establishment Name Address ID/FEI Business Operations CitraGen Pharmaceuticals Inc 024949457 manufacture(70369-002)