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| Product NDC Code | 36800-342 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Maximum strength antacid mint |
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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 | part331 | ||||||
| Labeler Name | Topco Associates, LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 to 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.Maximum Strength Antacid Mint aluminum hydroxide, magnesium hydroxide, simethicone ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION DIMETHICONE DIMETHICONE ALCOHOL GLYCERIN HYDROXYETHYL CELLULOSE, UNSPECIFIED METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SORBITOL
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 Topcare Health COMPARE TO MYLANTA ® MAXIMUM STRENTH ACTIVE INGREDIENTS* NDC 36800-342-40 MAXIMUM STRENGTH Antacid Advanced ANTACID & ANTIGAS FAST RELIEF Heartburn Acid Indigestion Pressure Bloating (Gas) ALCOHOL 0.2% v/v MINT FLAVOR 12 FL OZ (355 mL) 517
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 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 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