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Advanced antacid regular strength - Medication Information

Product NDC Code 49348-153
Drug Name

Advanced antacid regular strength

Type Brand
Pharm Class Calculi Dissolution Agent [EPC],
Increased Large Intestinal Motility [PE],
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],
Magnesium Ion Exchange Activity [MoA],
Osmotic Activity [MoA],
Osmotic Laxative [EPC],
Skin Barrier Activity [PE],
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Active Ingredients
Aluminum hydroxide 200 mg/5ml
Dimethicone 20 mg/5ml
Magnesium hydroxide 200 mg/5ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 307746
Application Number M001
Labeler Name STRATEGIC SOURCING SERVICES LLC
Packages
Package NDC Code Description
49348-153-39 355 ml in 1 bottle (49348-153-39)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each 5 mL teaspoonful) Aluminum hydroxide 200mg (equivalent to dried gel, USP) Magnesium hydroxide 200 mg Simethicone 20mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 under 12 years: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses relieves heartburn sour stomach acid indigestion the symptoms referred to as gas

Purpose

Information about the drug product’s indications for use.
Purposes Antacid Antigas

Spl product data elements

Usually a list of ingredients in a drug product.
ADVANCED ANTACID REGULAR STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone BENZYL ALCOHOL BUTYLPARABEN CETYL HYDROXYETHYLCELLULOSE (350000 MW) PROPYLPARABEN WATER SACCHARIN SODIUM SORBITOL ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION DIMETHICONE DIMETHICONE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
package label Sunmark compare to active ingredients of the Regular Strength Mylanta®* NDC 49348-153-39 advanced antacid Regular Strength antacid/antigas Alumina, Magnesia and Simethicone Oral Suspension Fast acting soothing relief of heartburn, acid indigestion, sour stomach, pressure & bloating ORIGINAL FLAVOR Alcohol 0.15% 12 FL OZ (355 mL) sun rs

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children.

Storage and handling

Information about safe storage and handling of the drug product.
Other information each 5 mL teaspoonful contains: magnesium 85 mg, sodium 1 mg protect from freezing store at room temperature keep tightly closed

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API