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Citroma - Medication Information

Product NDC Code 68016-696
Drug Name

Citroma

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]
Active Ingredients
Magnesium citrate 1.745 g/29.6ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 1052760,
1245168
Application Number M007
Labeler Name Pharmacy Value Alliance LLC
Packages
Package NDC Code Description
68016-696-38 296 ml in 1 bottle, plastic (68016-696-38)
Check if available Online

Adverse reactions

Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.
Adverse Reaction Distributed by: Pharmacy Value Alliance LLC 407 East Lancaster Avenue, Wayne, PA 19087 INDEPENDENTLY TESTED SATISFACTION GUARANTEED If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

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 Magnesium Citrate BENZOIC ACID CITRIC ACID MONOHYDRATE EDETATE DISODIUM ANHYDROUS SUCRALOSE WATER MAGNESIUM CITRATE 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 DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING Premier Value Magnesium Citrate saline lazative oral solution Non-pasteurized Saccharin free BPA free Dye Free Lemon Flavor INDEPENDENTLY TESTED SATISFACTION GUARANTEED 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.
Claims Non-USP: Non-Carbonated, Non-Pasteurized; Contains Preservatives

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 that 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 Store at temperatures between 46° and 86°F (8° and 30° C)

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 feeding
if pregnant or breast-feeding ask help professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store at temperatures between 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