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Antacid - Medication Information

Product NDC Code 63868-173
Drug Name

Antacid

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 400 mg/10ml
Dimethicone 40 mg/10ml
Magnesium hydroxide 400 mg/10ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 307746
Application Number part331
Labeler Name Chain Drug Marketing Association Inc.
Packages
Package NDC Code Description
63868-173-12 355 ml in 1 bottle (63868-173-12)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS (in each 10 mL ) Aluminum hydroxide (equiv. to dried gel, USP) 400 mg Magnesium hydroxide 400 mg Simethicone 40 mg

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 mL = milliliter adults and children 12 years and older: take 10 mL to 20 mL four times a day, or as directed by a doctor children under 12 years: consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

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.
USE(S) relieves: acid indigestion heartburn sour stomach upset stomach and gas associated with these symptoms

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Antacid aluminum hydroxide, magnesium hydroxide, simethicone ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION DIMETHICONE DIMETHICONE ALCOHOL GLYCERIN HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SORBITOL Mint

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.
PRINCIPAL DISPLAY PANEL NDC 63868-173-12 QC QUALITY CHOICE Regular strength Antacid Liquid Antacid & Antigas Aluminum Hydroxide 400 mg Magnesium Hydroxide 400 mg Simethicone 40 mg Relieves: Acid Indigestion Heartburn Sour Stomach Pressure & Bloating Original Flavor Alcohol content 0.2% v/v 12 FL OZ (355 mL) 509-QC

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
ASK A DOCTOR BEFORE USE IF YOU HAVE kidney disease a magnesium-restricted diet

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE presently taking a prescription drug. Antacids may interact with certain prescription drugs.

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 .

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
STOP USE AND ASK DOCTOR if symptoms last more than two weeks

Storage and handling

Information about safe storage and handling of the drug product.
OTHER INFORMATION each 10 mL contains: magnesium 170 mg, sodium 5 mg store at controlled room temperature 20ºC-25ºC (68º-77ºF) do not freeze

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 Do not take more than 80 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

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