Label: RUGBY ALMACONE- aluminum hydroxide, magnesium hydroxide, simethicone suspension
- NDC Code(s): 0536-1185-83
- Packager: Rugby Laboratories
- 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.
Updated January 7, 2019
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- Active ingredients (in each 10 mL)
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 exceed 120 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, unless directed by a doctor
- shake well before use
- measure with dosing cup provided
- adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor
- do not take more than 120 mL in any 24 hour period
- do not use the maximum dosage for more than 2 weeks
- children under 12 years: ask a doctor
- mL = milliliter
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
INGREDIENTS AND APPEARANCE
aluminum hydroxide, magnesium hydroxide, simethicone suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1185 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:0536-1185-83 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 12/19/2018 Labeler - Rugby Laboratories (079246066)