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NDC 36800-0582-40 Regular Strength Antacid Mint 400; 40; 400 mg/10mL; mg/10mL; mg/10mL Details

Regular Strength Antacid Mint 400; 40; 400 mg/10mL; mg/10mL; mg/10mL

Regular Strength Antacid Mint is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates, LLC. The primary component is ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE.

MedlinePlus Drug Summary

Aluminum Hydroxide, Magnesium Hydroxide are antacids used together to relieve heartburn, acid indigestion, and upset stomach. They may be used to treat these symptoms in patients with peptic ulcer, gastritis, esophagitis, hiatal hernia, or too much acid in the stomach (gastric hyperacidity). They combine with stomach acid and neutralize it. Aluminum Hydroxide, Magnesium Hydroxide are available without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 36800-0582-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Aluminum Hydroxide and Magnesium Hydroxide

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 36800-0582-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	36800-0582
Product ID	36800-582_59c16c09-c23d-4a37-8460-d6c00a268ed5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Regular Strength Antacid Mint
Proprietary Name Suffix	n/a
Non-Proprietary Name	aluminum hydroxide, magnesium hydroxide, simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	400; 40; 400
Active Ingredient Units	mg/10mL; mg/10mL; mg/10mL
Substance Name	ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
Labeler Name	Topco Associates, LLC
Pharmaceutical Class	Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part331
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0582-40 (36800058240)

Pricing Information	N/A
NDC Package Code	36800-582-40
Billing NDC	36800058240
Package	355 mL in 1 BOTTLE (36800-582-40)
Marketing Start Date	2020-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 59c16c09-c23d-4a37-8460-d6c00a268ed5 Details

ACTIVE INGREDIENTS (in each 10 mL )

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

PURPOSE

Antacid

Antacid

Antigas

USE(S)

relieves:

acid indigestion
heartburn
sour stomach
upset stomach and gas associated with these symptoms

WARNINGS

Do not take more than 80 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

ASK A DOCTOR BEFORE USE IF YOU HAVE

kidney disease
a magnesium-restricted diet

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

STOP USE AND ASK DOCTOR

if symptoms last more than two weeks

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS

shake well before use
adults and children 12 years and older: take 10 mL to 20 mL four times a day, or as directed by a doctor
children under 12 years: consult a doctor
mL = milliliter

OTHER INFORMATION

each 10 mL contains: magnesium 170 mg, sodium 5 mg
store at 20ºC-25ºC (68º-77ºF)
do not freeze

INACTIVE INGREDIENTS

ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

PRINCIPAL DISPLAY PANEL

Topcare Health

NDC 36800-582-40

REGULAR STRENGTH

Antacid

Advanced

ANTACID & ANTIGAS

FAST RELIEF

Heartburn
Acid Indigestion
Pressure
Bloating (Gas)

ALCOHOL 0.4% v/v

12 FL OZ (355 mL)

MINT FLAVOR

INGREDIENTS AND APPEARANCE

REGULAR STRENGTH ANTACID MINT

aluminum hydroxide, magnesium hydroxide, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-582
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	400 mg in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	400 mg in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-582-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part331	10/01/2020

Labeler - Topco Associates, LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	MANUFACTURE(36800-582)

Revised: 10/2020

Document Id: 59c16c09-c23d-4a37-8460-d6c00a268ed5

Set id: 59c16c09-c23d-4a37-8460-d6c00a268ed5

Version: 1

Effective Time: 20201001