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Product NDC Code | 68016-850 | ||||
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Drug Name | Premier value milk of magnesia |
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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], 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 | 253017 | ||||
Application Number | M001 | ||||
Labeler Name | Pharmacy Value Alliance, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Magnesium Hydroxide 400 mg per teaspoon (5 mL)
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) As an antacid: Adults and children 12 yrs. of age and older: 1 to 3 teaspoonfuls with a little water, or as directed by a doctor. As a laxative: Adults and children 12 yrs. of age and older: 1 to 4 tablespoonfuls followed by a full 8 oz. glass of water. Children 6 thru 11 yr. of age: 1 to 2 tablespoonfuls followed by a full 8 oz. glass of water. children 2 thru 5 yrs. of age: 1 to 3 teaspoonfuls followed by a full 8 oz. glass of water. Children under 2 yrs. of age: consult a doctor before use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient. Purified water
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 As an antacid: helps relieve acid ingestion, heartburn and sour stomach. As a laxative: For the temporary relief of occasional constipation. Bowel movement is generally produced in 1.2 to 6 hours.
Purpose
Information about the drug product’s indications for use.Purpose Antacid/Saline Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Premier Value Milk of Magnesia Magnesium Hydroxide WATER MAGNESIUM HYDROXIDE MAGNESIUM CATION
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 PV MOM 060221.jpg
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 the case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information acid neutralizing capacilty: 10.0 mEq per teaspoon. keep tightly closed and avoid freezing.
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 you have rectal bleeding or have no bowel movement after using this product. this could be signs of a serious codition, if you need to use a laxative for more than one week. Frequent or prolonged use may result in the dependence on laxatives.
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. As an antacid, do not take more than the maximum recomended daily dose in a 24 hr. period or take the maximum dose for more than two weeks, except under the advise of a doctor. May have laxative effect. If pregnant or breastfeeding ask a health professional before use.
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. Abdominal pain, nausea, vomiting, kidney desease, are on a magnesium restricted diet, a sudden change in bowel habits lasting longer than 14 days, if you are taking prescription drugs. Antacids may interact with certain prescription drugs.
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