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NDC 69842-0508-05 Antacid 400; 40; 400 mg/5mL; mg/5mL; mg/5mL Details

Antacid 400; 40; 400 mg/5mL; mg/5mL; mg/5mL

Antacid is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by CVS. 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: 69842-0508-05
Last Updated: 12/01/2022
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: 69842-0508-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	69842-0508
Product ID	69842-508_3557256e-e823-4bb3-85db-ca11abbea728
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	Antacid
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aluminum Hydroxide, Magnesium Hydroxide and Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	400; 40; 400
Active Ingredient Units	mg/5mL; mg/5mL; mg/5mL
Substance Name	ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
Labeler Name	CVS
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	part332
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0508-05 (69842050805)

Pricing Information	N/A
NDC Package Code	69842-508-05
Billing NDC	69842050805
Package	355 mL in 1 BOTTLE (69842-508-05)
Marketing Start Date	2011-03-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d97cd600-6fc4-4d39-9e41-344e44646506 Details

Active ingredient (in each 5mL tsp.)

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

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpose

Antacid

Antigas

Uses

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

Warnings

Do not take more than 8 teaspoonfuls 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 a 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 2 to 4 teaspoonfuls two times a day, or as directed by a doctor
children under 12 years: consult a doctor

Other information

each teaspoon contains: magnesium 170 mg, sodium 5 mg
store at controlled room temperature 20oC-25oC (68oF-77oF)
do not freeze

Inactive ingredients

flavor, glycerin, hydroxyethylcellulose, methylparaben, propylene glycol, purified water, saccharin sodium, simethicone emulsion, sorbitol

PDP

Compare to the active ingredients in Maalox max

Maximum strength Antacid Liquid

Antacid / Anti-gas

Fast relief of:

Heartburn

Acid indigestion

Pressure & Bloating

Cherry Flavor

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

ANTACID

aluminum hydroxide, magnesium hydroxide and simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-508
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 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	400 mg in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-508-05	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	03/09/2011

Labeler - CVS (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	manufacture(69842-508)

Revised: 8/2017

Document Id: 3557256e-e823-4bb3-85db-ca11abbea728

Set id: d97cd600-6fc4-4d39-9e41-344e44646506

Version: 1

Effective Time: 20170809