INON ACE- magnesium aluminosilicate, magnesium hydroxide solution

Inon Ace by

Drug Labeling and Warnings

Inon Ace by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each bottle)
Magnesium Aluminosilicate 900 mg
Magnesium Hydroxide 250 mg

PURPOSE

Purpose
Magnesium Aluminosilicate     Antacid
Magnesium Hydroxide     Antacid

INDICATIONS & USAGE

Uses relieves these symptoms:
■ heartburn    ■ sour stomach    ■ acid indigestion

WARNINGS

Warnings

Do not use this product if you are taking a prescription antibiotic drug containing any
form of tetracycline.

Ask a doctor or pharmacist before use if you are presently taking a prescription drug.
Antacids may interact with certain prescription drugs.

When using this product
■ do not take more than 2 bottles (adults and children 12 years and over) 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.
■ may have a laxative effect.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions
■ adults and children 12 years and over: Take 1 bottle (30mL) at a time 2 times daily,    
    between meals, or as directed by a doctor.
■ children under 12 years: Ask a doctor.
■ shake well before use.

OTHER SAFETY INFORMATION

Other information
■ each bottle contains: sodium 15 mg, magnesium 165 mg

INACTIVE INGREDIENT

Inactive ingredients  alcohol, butylparaben, citric acid, flavors (cinnamon oil, fluid
extract of ginger root, spearmint oil), hydroxypropylstarch, PEG-60 hydrogenated castor
oil, propylparaben, sodium benzoate, sodium citrate, sorbitol, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INON ACE 
magnesium aluminosilicate, magnesium hydroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-403
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILODRATE (UNII: 9T3UU8T0QK) (SILODRATE - UNII:9T3UU8T0QK)	SILODRATE	900 mg  in 30 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	250 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)
POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CINNAMON (CINNAMON OIL) , MINT (MENTHA OIL) , GINGER (GINGER, LIQUID EXTRACT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-403-01	2 in 1 CARTON	05/20/2000
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	05/20/2000

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-403) , label(49873-403) , pack(49873-403)