Label: ADVANCED ANTACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone liquid
- NDC Code(s): 49348-153-39
- Packager: STRATEGIC SOURCING SERVICES LLC
- 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 25, 2019
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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 dietAsk a doctor or pharmacist before use if you are taking a
prescription drug. Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if symptoms last more than 2 weeks
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
-
package label
Sunmark
compare to active ingredients of the Regular Strength Mylanta®*
NDC 49348-153-39
advanced
antacid
Regular Strength
antacid/antigas
Alumina, Magnesia
and Simethicone
Oral SuspensionFast acting
soothing relief of
heartburn,
acid indigestion,
sour stomach,
pressure & bloatingORIGINAL FLAVOR
Alcohol 0.15%
12 FL OZ (355 mL)
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INGREDIENTS AND APPEARANCE
ADVANCED ANTACID REGULAR STRENGTH
aluminum hydroxide, magnesium hydroxide, dimethicone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-153 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) CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-153-39 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 06/01/2012 Labeler - STRATEGIC SOURCING SERVICES LLC (116956644) Registrant - GCP Laboratories (965480861) Establishment Name Address ID/FEI Business Operations GCP Laboratories 965480861 manufacture(49348-153)