Label: INON ACE- silodrate and magnesium hydroxide solution
- NDC Code(s): 49873-403-01
- Packager: Sato Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- ACTIVE INGREDIENT
Active ingredients (in each bottle)Close
Magnesium Aluminosilicate 900 mg
Magnesium Hydroxide 250 mg
Magnesium Aluminosilicate Antacid
Magnesium Hydroxide Antacid
- INDICATIONS & USAGE
Uses relieves these symptoms:Close
■ heartburn ■ sour stomach ■ acid indigestion
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-hours
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 laxative effect.
- DOSAGE & ADMINISTRATION
■ 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
■ Each bottle contains: sodium 15 mg, magnesium 165 mg
- INACTIVE INGREDIENT
Inactive ingredients alcohol, butylparaben, citric acid, flavors (cinnamon oil, fluidClose
extract of ginger root, spearmint oil), hydroxypropylstarch, PEG-60 hydrogenated castor
oil, propylparaben, sodium benzoate, sodium citrate, sorbitol, water.
- INGREDIENTS AND APPEARANCE
magnesium aluminosilicate, magnesium hydroxide solution
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49873-403 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILODRATE (SILODRATE) SILODRATE 900 mg in 30 mL MAGNESIUM HYDROXIDE (MAGNESIUM CATION) MAGNESIUM HYDROXIDE 250 mg in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL BUTYLPARABEN CITRIC ACID MONOHYDRATE HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) POLYOXYL 60 HYDROGENATED CASTOR OIL PROPYLPARABEN SODIUM BENZOATE SODIUM CITRATE SORBITOL WATER 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 1 30 mL in 1 BOTTLE 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)