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| Product NDC Code | 50804-164 | ||||
|---|---|---|---|---|---|
| Drug Name | Citroma |
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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 | LIQUID | ||||
| Application Number | part334 | ||||
| Labeler Name | Perrigo Direct, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each fl oz) Magnesium citrate 1.745g
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 drink a full glass (8 ounces) of liquid with each dose may be taken as a single daily dose or in divided doses adults and children 12 years of age and over - 6.5 to 10 fl oz in 24 hours children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours children 2 to under 6 years of age - 2 to 3 fl oz in 24 hours children under 2 years of age - ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzoic acid, citric acid, disodium EDTA, flavor, sucralose, 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.Uses for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours
Purpose
Information about the drug product’s indications for use.Purpose Saline laxative
Spl product data elements
Usually a list of ingredients in a drug product.citroma Magesium Citrate MAGNESIUM CITRATE MAGNESIUM CATION BENZOIC ACID CITRIC ACID MONOHYDRATE EDETATE DISODIUM ANHYDROUS SUCRALOSE water
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 Panel Display NDC 50804-164-38 GOODSENSE DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING Magnesium Citrate Saline Laxative Oral Solution Non-pasteurized Saccharin free Cherry Flavor 10 FL OZ (296 mL) image description
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.Non-USP: Non-Carbonated, Non-Pasteurized; Contains Preservatives
Distributed By: Perrigo Direct, Inc. Peachtree City, GA 30269 1-888-593-0593 www.PerrigoDirect.com GoodSense is a registered trademark of L. Perrigo Company.
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 abdominal pain, nausea, or vomiting noticed a sudden change in bowel habits tat persists over a period of 2 weeks already used a laxative for a period longer than 1 week
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 taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.other information each fl oz contains: magnesium 290 mg each fl oz contains: sodium 1 mg
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Call 1-888-593-0593
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 failure to have a bowel movement after use. These could be signs of a serious condition.
Pregnancy or breast feeding
Pregnancy or Breast feedingif pregnant or breast-feeding ask help professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Store at temperatures betweem 46° and 86°F (8° and 30°C)
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 for this product
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