OHTAS ISAN ANTACID

Main information

  • Trade name:
  • OHTAS ISAN ANTACID - calcium carbonate, sodium bicarbonate powder
  • Composition:
  • Calcium Carbonate 1 g in 1 g
  • Administration route:
  • ORAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OHTAS ISAN ANTACID - calcium carbonate, sodium bicarbonate powder
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Precipitated calcium carbonate ............. Antacid Sodium bicarbonate ............................. Antacid relieves: ■ heartburn ■ sour stomach ■ acid indigestion ■ upset stomach due to these symptoms ■ presently taking a prescription drug. Antacids may interact with certain prescription drugs. ■ on a sodium-restricted diet.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 49631-178-21, 49631-178-22
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 6 31-178

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Ca lcium Ca rbo na te (UNII: H0 G9 379 FGK) (Carbo nate Io n - UNII:7UJQ5OPE7D)

Calcium Carbo nate

1 g in 1 g

So dium Bica rbo na te (UNII: 8 MDF5V39 QO) (Bicarbo nate Io n - UNII:HN1ZRA3Q20 )

So dium Bicarbo nate

1 g in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

OHTA'S ISAN CO., LTD

Cinna mo n (UNII: 5S29 HWU6 QB)

Ta ng erine (UNII: KH3E30 9 6 OO)

Clo ve (UNII: K48 IKT5321)

Fennel (UNII: 557II4LLC3)

Gentia na Lutea Ro o t (UNII: S72O328 4MS)

Levo mentho l (UNII: BZ1R15MTK7)

Nutmeg (UNII: AEE24M3MQ9 )

Picra sma Q ua ssio ides Wo o d (UNII: 75EIV4LX7W)

Ma g nesium Ca rbo na te (UNII: 0 E53J9 27NA)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 6 31-178 -21

75 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:49 6 31-178 -22

140 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt331

10 /16 /20 0 0

Labeler -

OHT A'S ISAN CO., LT D (690771738)

Revised: 3/2016