Label: ALMACONE- aluminum hydroxide, magnesium hydroxide, simethicone tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 0536-3504-01 - Packager: Rugby Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 December 1, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- QUESTIONS
- DO NOT USE
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALMACONE
aluminum hydroxide, magnesium hydroxide, simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3504 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM HYDROXIDE 200 mg MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 200 mg DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O, SILICON DIOXIDE - UNII:ETJ7Z6XBU4) DIMETHICONE 20 mg Inactive Ingredients Ingredient Name Strength DEXTROSE (UNII: IY9XDZ35W2) SUCROSE (UNII: C151H8M554) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (White) Score no score Shape ROUND (Tablet) Size 16mm Flavor PEPPERMINT (peppermint flavor) Imprint Code 049 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-3504-01 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 08/23/2010 Labeler - Rugby Laboratories, Inc. (109178264) Registrant - Advance Pharmaceutical, Inc. (187824339) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical, Inc. 187824339 manufacture, repack, relabel