Mi-acid Regular Strength
FDA Label NDC 76413-319

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Central Texas Community Health Centers for the product Mi-acid Regular Strength (NDC 76413-319). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 5 ml teaspoonful), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Otc - Keep Out Of Reach Of Children

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.

Principal Display Panel (355 ML Bottle Label)

Principal Display Panel (355 ML Bottle Label)

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