SODIUM BICARBONATE - sodium bicarbonate tablet
Aphena Pharma Solutions - Tennessee, LLC
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.
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Uses: relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms
Warnings
Do not take more than 24 tablets for adults up to 60 years of age (or 12 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 before use if you have a sodium restricted diet.
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if symptoms last more than 2 weeks
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Directions
Other Information: Each tablet contains: sodium 178 mg (7.74 mEq) • store at room temperature 15°-30°C (59°-86°F) in a well closed container as defined in the USP.
Inactive Ingredients: Croscarmellose sodium NF, microcrystalline cellulose NF, silica NF, stearic acid NF and talc USP.
11790-11-16 REV 11/16
Manufactured for: Manufactured by:
Rising Pharmaceuticals, Inc. Contract Pharmacal Corp.
Allendale, NJ 07401 Hauppauge, NY 11788
Lot No.:
Exp. Date:
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count | 10 gr |
60 | 71610-438-53 |
90 | 71610-438-60 |
120 | 71610-438-70 |
180 | 71610-438-80 |
360 | 71610-438-94 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20200706JH
SODIUM BICARBONATE
sodium bicarbonate tablet |
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Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Aphena Pharma Solutions - Tennessee, LLC | 128385585 | REPACK(71610-438) |