Antacid
FDA Label NDC 53807-126

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Antacid (NDC 53807-126). 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 = 1 teaspoonful), purpose, uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, keep out of reach of children., directions, 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 = 1 Teaspoonful)

Aluminum hydroxide (Equi. To Dried Gel, USP) 200 mg

Magnesium hydroxide 200 mg

Simethicone 20 mg

Purpose

Antacid

Antigas

Uses

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • associated symptoms of gas and upset stomach
  • overindulgence of food and drink

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 for more than 2 weeks

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

  • shake well before each use
  • Adults/children 12 years and older, take 2 - 4 teaspoonsful between meals, at bedtime or as directed by a physician
  • do not take more than 12 teaspoonsful in 24
  • do not use the maximum dosage for more than 2 weeks
  • children under 12 years: consult a physician

Other Information

  • TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
  • Store at room temperature 15° - 30°C (59° - 86°F)
  • keep tightly closed
  • protect from freezing
  • each teaspoon (5 mL) contains: magnesium 83 mg
  • each teaspoon (5 mL) contains: sodium 1 mg
  • does not meet USP requirements for preservative effectiveness

Inactive Ingredients

flavors, hypromellose, parabens, saccharin, sodium hypochlorite, sorbitol, water and xanthan gum

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