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Product NDC Code | 30142-637 | ||||||
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Drug Name | Regular strength 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 | 307746 | ||||||
Application Number | M001 | ||||||
Labeler Name | KROGER COMPANY | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each 10 mL dose) Aluminum hydroxide 400 mg (equivalent to dried gel, USP) 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 adults and children 12 years and older: take 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime, or as directed by a doctor. children under under 12 years: ask a doctor measure with dosing cup provided mL=milliliter
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, 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 sour stomach acid indigestion the symptoms 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.REGULAR STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone BUTYLPARABEN PROPYLPARABEN WATER SACCHARIN SODIUM SORBITOL SOLUTION ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION DIMETHICONE DIMETHICONE HYDROXYETHYL CELLULOSE, UNSPECIFIED BENZYL ALCOHOL
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.package label 1
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.
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? 1-800-632-6900
Storage and handling
Information about safe storage and handling of the drug product.Other information each 10 mL dose contains: magnesium 165 mg, sodium 6 mg protect from freezing store at room temperature keep tightly closed
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 120 mL (12 doses) in a 24 hour period or use the maximum dosage for more than 2 weeks . 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
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