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| Product NDC Code | 55319-528 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Antacid antigas maximum strength |
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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 | Family Dollar (FAMILY WELLNESS) | ||||||
| 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 ingredient (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 using mL = milliliter do not take more than 60 mL in 24 hours or use the maximum dosage for more than 2 weeks measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product adults and children12 years and older: take 10-20 mL as needed, between or after meals, at bedtime, or as directed by a doctor children under 12 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, carboxymethylcellulose sodium, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum
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 for the relief of acid indigestion heartburn sour stomach upset stomach associated with these symptoms pressure and bloating commonly referred to as gas overindulgence in food and drink
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 antigas Maximum Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION DIMETHICONE DIMETHICONE BENZYL ALCOHOL CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN MICROCRYSTALLINE CELLULOSE WATER SODIUM CARBONATE SORBITOL SUCRALOSE XANTHAN GUM
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 THE ACTIVE INGREDIENTS IN MYLANTA® MAXIMUM STRENGTH* MAXIMUM STRENGTH Antacid & Anti-gas Relief Multi-Symptom Relief Aluminum Hydroxide - Antacid Magnesium Hydroxide - Antacid Simethicone - Antigas For Fast Relief of: Heartburn Acid Indigestion Pressure Bloating Alcohol-Free Sugar-Free Paraben-Free ORIGINAL FLAVOR * This product is not manufactured or distributed by McNeil Consumer Pharmaceuticals Co., distributor of Mylanta® Maximum Strength. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: MIDWOOD BRANDS, LLC 10611 MONROE RD.MATTHEWS, NC 28105
Product Label FAMILY WELLNESS Maximum Strength Antacid & Antigas Relief Aluminum hydroxide 800 mg, Magnesium hydroxide 800 mg, Simethicone 80 mg
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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not take more than 60 mL in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physican
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 (1-800-222-1222) right away.
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? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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 a doctor if symptoms last more than 2 weeks.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information each 10 mL contains: magnesium 335 mg, sodium 10 mg store between 20-25°C (68-77°F).Avoid freezing
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 for more than 2 weeks except under the advice and supervision of a physican 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. 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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