Label: MI ACID- aluminum hydroxide, magnesium hydroxide, simethicone suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-6833-1 - Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 0904-6833
- 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 September 23, 2020
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- Official Label (Printer Friendly)
- Active ingredients (in each 10 mL)
- Purposes
- Uses
- Warnings
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Directions
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- shake well before use
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- measure with dosing cup provided
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- adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor
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- do not take more than 120 mL in any 24 hour period
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- do not use the maximum dosage for more than 2 weeks
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- children under 12 years: ask a doctor
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- mL = milliliter
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
MI ACID
aluminum hydroxide, magnesium hydroxide, simethicone suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-6833(NDC:0904-6833) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 400 mg in 10 mL MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 400 mg in 10 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 40 mg in 10 mL Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYLPARABEN (UNII: 3QPI1U3FV8) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) PEPPERMINT OIL (UNII: AV092KU4JH) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color WHITE (opaque) Score Shape Size Flavor MINT, LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-6833-1 50 in 1 BOX, UNIT-DOSE 09/23/2020 1 30 mL in 1 CUP, UNIT-DOSE; 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 12/28/2018 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 relabel(17856-6833) , repack(17856-6833)
