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Product NDC Code | 83324-122 | ||||||
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Drug Name | Qch maximum strength antacid 516 |
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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] |
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Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | LIQUID | ||||||
RxCUI drug identifier | 237870 | ||||||
Application Number | M001 | ||||||
Labeler Name | Chain Drug Marketing Association Inc. | ||||||
Packages |
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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) 800 mg Magnesium hydroxide 800 mg Simethicone 80 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 adults and children 12 years and older: take 10 mL - 20 mL two times a day, or as directed by a doctor children under 12 years: consult a doctor mL = milliliter
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.QCH Maximum Strength Antacid 516 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 Lemon 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 83324-122-12 QC QUALITY CHOICE *Compare to the Active Ingredients in Mylanta ® Maximum Strength Maximum Strength Antacid Liquid Antacid & Antigas Aluminum Hydroxide 800 mg Magnesium Hydroxide 800 mg Simethicone 80 mg Relieves: Acid Indigestion Heartburn Sour Stomach Pressure & Bloating Original Flavor Alcohol content 0.2% v/v 12 FL OZ (355 mL) qch-509.jpg
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 340 mg, sodium 5 mg store at 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 60 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