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Onelax saline laxative - Medication Information

Product NDC Code 71399-0053
Drug Name

Onelax saline laxative

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
Application Number M007
Labeler Name AKRON PHARMA INC
Packages
Package NDC Code Description
71399-0053-1 296 ml in 1 bottle (71399-0053-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (30ml (approx. 1 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 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 1/2 bottle to 1 bottle (10 fl oz) children 6 to 11 years of age 1/3 bottle to 1/2 bottle children under 6 years of age consult a doctor
adults and children 12 years of age and over 1/2 bottle to 1 bottle (10 fl oz)
children 6 to 11 years of age 1/3 bottle to 1/2 bottle
children under 6 years of age consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients citric acid, disodium edetate, cherry flavor, purified water, saccharin sodium, sodium benzoate, sorbic acid

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 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.
OneLAX Saline Laxative Magnesium Citrate MAGNESIUM CITRATE MAGNESIUM CATION ANHYDROUS CITRIC ACID EDETATE DISODIUM WATER SACCHARIN SODIUM SODIUM BENZOATE SORBIC ACID

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.
cherry

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.
Other information each fliud ounce contains: magnesium 280 mg, sodium 6.7 mg store between 46º-86ºF (8º-30ºC). Do not refrigerate. protect from excessive heat and freezing discard unused product within 24 hours of opening bottle

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 a sodium restricted diet stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more 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 presently taking a prescription drug.

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 use laxative products for longer than 1 week unless directed by a doctor.

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 toll-free 1-877-225-6999. Manufactured for: Akron Pharma Inc., Fairfield, NJ-07004 www.akronpharma.com

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 no bowel movement after use. These could be signs of a serious condition.

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 do not exceed the maximum recommended daily dosage in a 24 hour period.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, 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 Do not use laxative products for longer than 1 week unless directed by a doctor. Ask a doctor before use if you have kidney disease a magnesium restricted diet a sodium restricted diet stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more than 1 week Ask a doctor or pharmacist before use if you are presently taking a prescription drug. When using this product do not exceed the maximum recommended daily dosage in a 24 hour period. Stop use and ask a doctor if you have rectal bleeding or no bowel movement after use. These could be signs of a serious condition. 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