DailyMed - MI-ACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

Contains inactivated NDC Code(s)
NDC Code(s): 76413-319-01
Packager: Central Texas Community Health Centers
This is a repackaged label.
Source NDC Code(s): 0904-0004

Category: HUMAN OTC DRUG LABEL

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 April 19, 2016

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Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 200 mg (equivalent to dried gel, USP)

Magnesium hydroxide 200 mg

Simethicone 20mg
Purposes

Antacid

Antigas
Uses
relieves
- heartburn
- sour stomach
- acid indigestion
- the symptoms 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 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.

Keep out of reach of children.
Directions

• shake well before use

• adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor

• do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

• children under 12 years: ask a doctor
Other information

• each 5 mL teaspoonful contains: magnesium 85 mg, sodium 1 mg

• store at room temperature

• protect from freezing

• keep tightly closed

• TAMPER-EVIDENT: Do not use if breakaway band on bottle is missing or broken.
Inactive ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution
PRINCIPAL DISPLAY PANEL - 355 ML Bottle Label

CommUnityCare Federally Qualified Health Centers

MI-ACID
ALT
MAALOX
R.S.
355ML

Date:

Name:
Dr.

USE AS DIRECTED. (Alternative for Maalox R.S.)

123456

1/1/01

MI-ACID REG. STRENGTH 355ML NDC 76413-319-01

Batch: 123456
Lot: 123456
Exp: 1/1/01
MAJOR

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

INGREDIENTS AND APPEARANCE

MI-ACID REGULAR STRENGTH
aluminum hydroxide, magnesium hydroxide, dimethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76413-319(NDC:0904-0004)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON (lemon)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76413-319-01	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	02/01/2011

Labeler - Central Texas Community Health Centers (079674019)

Name	Address	ID/FEI	Business Operations
Establishment
Central Texas Community Health Centers		079674019	REPACK(76413-319) , RELABEL(76413-319)

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Published Date (What is this?)	Version	Files
Apr 20, 2016	1 (current)	download

	RxCUI	RxNorm NAME	RxTTY
1	210036	Mi-Acid 200 MG / 200 MG / 20 MG in 5 mL Oral Suspension	PSN
2	210036	aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension [Mi-Acid]	SBD
3	210036	Mi-Acid (aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG) per 5 ML Oral Suspension	SY
4	210036	Mi-Acid (aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG) per 10 ML Oral Suspension	SY
5	210036	Mi-Acid (aluminum hydroxide 40 MG / magnesium hydroxide 40 MG / simethicone 4 MG) per ML Oral Suspension	SY
6	307746	aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral Suspension	PSN
7	307746	aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension	SCD
8	307746	aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral Suspension	SY
9	307746	aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral Suspension	SY
10	307746	aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral Suspension	SY

RxCUI

RxNorm NAME

RxTTY

210036

Mi-Acid 200 MG / 200 MG / 20 MG in 5 mL Oral Suspension

PSN

210036

aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension [Mi-Acid]

SBD

210036

Mi-Acid (aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG) per 5 ML Oral Suspension

210036

Mi-Acid (aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG) per 10 ML Oral Suspension

210036

Mi-Acid (aluminum hydroxide 40 MG / magnesium hydroxide 40 MG / simethicone 4 MG) per ML Oral Suspension

307746

aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral Suspension

PSN

307746

aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension

SCD

307746

aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral Suspension

307746

aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral Suspension

307746

aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral Suspension

Label: MI-ACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

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Label: MI-ACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

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MI-ACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

Number of versions: 1

MI-ACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

MI-ACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

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MI-ACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.