NDC Code(s) : 42507-340-40
Packager : HyVee Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

antacidaluminum hydroxide, magnesium hydroxide, simethicone LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42507-340
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
(ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) 		ALUMINUM HYDROXIDE400 mg in 5 mL
MAGNESIUM HYDROXIDE(UNII: NBZ3QY004S)
(HYDROXIDE ION - UNII:9159UV381P) 		MAGNESIUM HYDROXIDE400 mg in 5 mL
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE40 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
HYPROMELLOSES(UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POTASSIUM CITRATE(UNII: EE90ONI6FF)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SORBITOL(UNII: 506T60A25R)
Product Characteristics
Color WHITE (opaque) Score
Shape Size
Flavor LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42507-340-40355 mL in 1 BOTTLE Type 0: Not a Combination Product21/10/1991
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 10/21/1991 03/24/2019

PRINCIPAL DISPLAY PANEL

Compare to Mylanta® Maximum Strength active ingredients

Maximum Strength

Antacid/Anti-Gas

Antacid

Fast Acting

Soothing Relief of

Heartburn

Acid Indigestion

Sour Stomach

Classic Original Flavor

12 FL OZ (355 mL)

Antacid Front LabelAntacid Front Label