Maximum Strength Antacid Suspension
FDA Label NDC 63868-715

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Maximum Strength Antacid (NDC 63868-715). 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 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40mg

Purposes

Antacid

Antigas

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach due to these symptoms
  • 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.

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 12 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 165 mg, sodium 1 mg

• store at room temperature and avoid freezing

 • close cap tightly after use

Inactive Ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

* Please review the disclaimer below.