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SODIUM BICARBONATE by Mirror Pharmaceuticals LLC

Dosage form: tablet
Ingredients: SODIUM BICARBONATE 650mg
Labeler: Mirror Pharmaceuticals LLC
NDC Code: 52682-206

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.

SODIUM BICARBONATE 10 gr (650 mg)

Drug Facts

Active Ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

Antacid

Indications:

Relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach

associated with these symptoms

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 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.

As with any drug, if you are pregnant or nursing a baby, seek advise of a health professional before using this product.

STOMACH WARNING:

TO AVOID SERIOUS INJURY, DO 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.

DRUG INTERACTION PRECAUTION:

Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.

Directions:
  • Adults - Take 1 tablet, dissolved in a glass of water, as needed.
  • Maximum daily dose for adults upto 60 years of age is 24 tablets.
  • Maximum daily dose for adults 60 years of age and older is 12 tablets.
  • Dissolve completely in water before drinking.
  • DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

Other Information:
  • each tablet contains: sodium 178 mg (7.74 meq)
  • store at room temperature 15°- 30°C (59°- 86°F) in well-closed containers as defined in the USP.

Inactive Ingredients:

Pregelatinized starch, NF and mieral oil, USP.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

SODIUM BICARBONATE 
sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52682-206
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE650 mg
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
STARCH, CORN 
Product Characteristics
ColorWHITE (White) Score2 pieces
ShapeROUND (round) Size11mm
FlavorImprint CodeCL;206
Contains    
Packaging
#Item CodePackage Description
1NDC:52682-206-041000 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/24/2011
Labeler - Mirror Pharmaceuticals LLC (964680206)
Registrant - Mirror Pharmaceuticals LLC (964680206)
Establishment
NameAddressID/FEIOperations
Mirror Pharmaceuticals LLC964680206manufacture

Revised: 04/2011
 
Mirror Pharmaceuticals LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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