Mi-acid Regular Strength
FDA Label NDC 64725-0004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tya Pharmaceuticals for the product Mi-acid Regular Strength (NDC 64725-0004). 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

taking a prescription drug. Ask a doctor or pharmacist before use if you are

Antacids may interact with certain prescription drugs.

symptoms last more than 2 weeks Stop use and ask a doctor if

ask a health professional before use. If pregnant or breast-feeding,

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

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

• 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

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