SODIUM BICARBONATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)

Available from:

Ingenus Pharmaceuticals NJ, LLC

INN (International Name):

SODIUM BICARBONATE

Composition:

SODIUM BICARBONATE 650 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antacid Relieves: - acid indigestion - heartburn - sour stomach - upset stomach associated with these symptoms

Authorization status:

OTC monograph final

Summary of Product characteristics

SODIUM BICARBONATE- SODIUM BICARBONATE TABLET
INGENUS PHARMACEUTICALS NJ, 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._
----------
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