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NDC 70795-1180-00 Sodium Bicarbonate 5 gr 325 mg/1 Details
Sodium Bicarbonate 5 gr 325 mg/1
Sodium Bicarbonate 5 gr is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by GRAXCELL PHARMACEUTICAL, LLC. The primary component is SODIUM BICARBONATE.
MedlinePlus Drug Summary
Sodium bicarbonate is an antacid used to relieve heartburn and acid indigestion. Your doctor also may prescribe sodium bicarbonate to make your blood or urine less acidic in certain conditions. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 70795-1180-00Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sodium Bicarbonate
Product Information
| NDC | 70795-1180 |
|---|---|
| Product ID | 70795-1180_d3addf66-3bb7-022c-e053-2a95a90af356 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Sodium Bicarbonate 5 gr |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sodium Bicarbonate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 325 |
| Active Ingredient Units | mg/1 |
| Substance Name | SODIUM BICARBONATE |
| Labeler Name | GRAXCELL PHARMACEUTICAL, LLC |
| Pharmaceutical Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 70795-1180-00 (70795118000)
| NDC Package Code | 70795-1180-0 |
|---|---|
| Billing NDC | 70795118000 |
| Package | 1000 TABLET in 1 BOTTLE (70795-1180-0) |
| Marketing Start Date | 2017-10-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 446d11a6-e92b-46e9-9a9f-b0bfbb2254f8 Details
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.
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
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| SODIUM BICARBONATE 5 GR
sodium bicarbonate tablet |
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| Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| GRAXCELL PHARMACEUTICAL, LLC | 056556923 | manufacture(70795-1180) | |
Revised: 12/2021
Document Id: d3addf66-3bb7-022c-e053-2a95a90af356
Set id: 446d11a6-e92b-46e9-9a9f-b0bfbb2254f8
Version: 4
Effective Time: 20211221