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NDC 41163-0357-40 Equaline Antacid 400; 40; 400 mg/10mL; mg/10mL; mg/10mL Details

Equaline Antacid 400; 40; 400 mg/10mL; mg/10mL; mg/10mL

Equaline Antacid is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Supervalu Inc. 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: 41163-0357-40
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: 41163-0357-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	41163-0357
Product ID	41163-357_2177cde6-227a-4f37-bca4-3fdc2b69b269
Associated GPIs	48991003101810
GCN Sequence Number	002701
GCN Sequence Number Description	mag hydrox/aluminum hyd/simeth ORAL SUSP 200-200-20 ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	63910
HICL Sequence Number	001168
HICL Sequence Number Description	MAGNESIUM HYDROXIDE/ALUMINUM HYDROXIDE/SIMETHICONE
Brand/Generic	Generic
Proprietary Name	Equaline Antacid
Proprietary Name Suffix	regular strength
Non-Proprietary Name	Aluminum hydroxide, Magnesium hydroxide, Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
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	Supervalu Inc
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	2023-12-31

Package

Package Images

NDC 41163-0357-40 (41163035740)

Pricing Information	N/A
NDC Package Code	41163-357-40
Billing NDC	41163035740
Package	355 mL in 1 BOTTLE (41163-357-40)
Marketing Start Date	2004-10-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 72b64f39-c0b5-4631-90ed-8967be2e1ee0 Details

Active ingredients (in each 10 mL)

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

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purposes

Antacid

Antigas

Uses

relieves

•: heartburn
•: acid indigestion
•: sour stomach
•: upset stomach due to these symptoms
•: pressure and bloating commonly referred to as gas

Warnings

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.

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

•: 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

•: each 10 mL contains: magnesium 175 mg
•: does not meet USP requirements for preservative effectiveness
•: store at 20-25°C (68-77°F), do not freeze

Inactive ingredients

butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, peppermint oil, propylparaben, purified water, simethicone emulsion, sorbitol, sorbitol solution

Questions or comments?

1-877-932-7948

Principal Display Panel

regular strength

antacid

(antacid - antigas)

works on contact

tough on heartburn

soothing relief of:

acid indigestion

sour stomach

classic original flavor

ALCOHOL 0.2%

12 FL OZ (355mL)

INGREDIENTS AND APPEARANCE

EQUALINE ANTACID REGULAR STRENGTH

aluminum hydroxide, magnesium hydroxide, simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-357
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, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	400 mg in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41163-357-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/27/2004

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	10/27/2004

Labeler - Supervalu Inc (006961411)

Revised: 12/2018

Document Id: 2177cde6-227a-4f37-bca4-3fdc2b69b269

Set id: 72b64f39-c0b5-4631-90ed-8967be2e1ee0

Version: 5

Effective Time: 20181210