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| Product NDC Code | 41250-340 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Antacid |
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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 | SUSPENSION | ||||||
| RxCUI drug identifier | 237870 | ||||||
| Application Number | part331 | ||||||
| Labeler Name | Meijer Distribution Inc | ||||||
| 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 • measure with dosing cup provided • adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor • do not take more than 60 mL in any 24 hour period • do not use the maximum dosage for more than 2 weeks • children under 12 years: ask a doctor • mL = milliliter
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, potassium citrate, propylparaben, purified water, simethicone emulsion, sorbitol, 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 • acid indigestion • sour stomach • upset stomach due to these symptoms • pressure and bloating commonly 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.antacid aluminum hydroxide, magnesium hydroxide, simethicone ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION DIMETHICONE DIMETHICONE SILICON DIOXIDE BUTYLPARABEN HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE CARBOXYMETHYLCELLULOSE SODIUM POTASSIUM CITRATE PROPYLPARABEN WATER SORBITOL opaque
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 Compare to Mylanta® Maximum Strength active ingredients MAXIMUM STRENGTH antacid Antacid | Anti-Gas RELIEF OF: Heartburn, Indigestion, Sour Stomach Classic Flavor Works on Contact Tough on Heartburn 12 FL OZ (355 mL) 340-6e-antacid-1.jpg 340-6e-antacid-2.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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-719-9260
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not exceed 60 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks
Storage and handling
Information about safe storage and handling of the drug product.Other information • each 10 mL contains: magnesium 350 mg, potassium 20 mg and sodium 3 mg • does not meet USP requirements for preservative effectiveness • store at 20-25 ° C (68-77 ° F), 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 Ask a doctor before use if you have • kidney disease • a magnesium-restricted diet Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not exceed 60 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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