OHTAS ISAN ANTACID- calcium carbonate, sodium bicarbonate powder

Summary of Product characteristics

                                OHTAS ISAN ANTACID- CALCIUM CARBONATE, SODIUM BICARBONATE POWDER
OHTA'S ISAN CO.,LTD.
_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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DRUG FACTS
_ACTIVE INGREDIENTS (IN EACH SPOONFUL)_
Precipitated calcium carbonate 497 mg
Sodium bicarbonate 600 mg
_PURPOSE_
Precipitated calcium carbonate ............. Antacid
Sodium bicarbonate ............................. Antacid
_USES_
relieves: ■ heartburn ■ sour stomach ■ acid indigestion ■
upset stomach due to these
symptoms
_WARNINGS_
DO NOT USE more than 3 spoonfuls in a 24-hour period, or use the
maximum dosage of
this product for more than 2 weeks, except under the advice and
supervision of a
physician.
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
■ presently taking a prescription drug. Antacids may interact with
certain prescription
drugs.
■ on a sodium-restricted diet.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
_DIRECTION_
take 1 spoonful (using the spoon included with this can) with water, 3
times daily.
_OTHER INFORMATION_
EACH SPOONFUL CONTAINS: sodium 164 mg.
INACTIVE INGREDIENTS
cinnamon bark, citrus unshiu peel, clove, fennel, gentian,
_l_-menthol, nutmeg, powdered
picrasma wood, magnesium carbonate.
PRINCIPAL DISPLAY PANEL - CAN LABEL
OHTA'S ISAN NDC 49631-178-21
ANTACID POWDER
NET WT 2.65 OZ (75g)
PRINCIPAL DISPLAY PANEL - CAN LABEL
OHTA'S ISAN NDC 49631-178-22
ANTACID POWDER
NET WT 4.94 OZ (140g)
OHTAS ISAN ANTACID
calcium carbonate, sodium bicarbonate powder
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:49631-178
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D)
CALCIUM CARBONATE
1 g in 1 g
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION -
UNII:HN1Z RA3Q20)
SODI
                                
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