Label: SODIUM BICARBONATE 5 GR- sodium bicarbonate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 70795-1180-0, 70795-1180-1, 70795-1180-5 - Packager: GRAXCELL PHARMACEUTICAL, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
- this product if you are on a sodium-restricted diet unless directed by a doctor
- Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age or older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
- As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product
Stomach Warning
- TO AVOID SERIOUS INJURY, D0 NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK
- Consult a doctor if severe stomach pain occurs after taking this product.
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Directions
Adults: Take 1 tablet, dissolved in a glass of water, as needed. Maxlmum daily dose for adults up to 60 years of age is 24 tablets.
Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking.
D0 NOT EXCEED RECOMMENDED DOSE
Not recommended for children.
- Other information
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE 5 GR
sodium bicarbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70795-1180 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 STARCH, CORN (UNII: O8232NY3SJ) MINERAL OIL (UNII: T5L8T28FGP) Product Characteristics Color white Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code G57 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70795-1180-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 10/02/2017 2 NDC:70795-1180-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/02/2017 3 NDC:70795-1180-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/02/2017 Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923) Establishment Name Address ID/FEI Business Operations GRAXCELL PHARMACEUTICAL, LLC 056556923 manufacture(70795-1180)
