Label: MI-ACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 64725-0004-1 - Packager: TYA Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 0904-0004
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 15, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL teaspoonful)
- Purposes
- Uses
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Warnings
Ask a doctor before use if you have
• kidney disease
• a magnesium-restricted diet
taking a prescription drug. Ask a doctor or pharmacist before use if you are
Antacids may interact with certain prescription drugs.
symptoms last more than 2 weeks Stop use and ask a doctor if
ask a health professional before use. If pregnant or breast-feeding,
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MI-ACID REGULAR STRENGTH
aluminum hydroxide, magnesium hydroxide, dimethicone suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64725-0004(NDC:0904-0004) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 200 mg in 5 mL MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 200 mg in 5 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 20 mg in 5 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor LEMON (lemon) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64725-0004-1 12 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/01/2011 Labeler - TYA Pharmaceuticals (938389038) Registrant - TYA Pharmaceuticals (938389038) Establishment Name Address ID/FEI Business Operations TYA Pharmaceuticals 938389038 RELABEL(64725-0004) , REPACK(64725-0004)