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Gavilax - Medication Information

Product NDC Code 63187-368
Drug Name

Gavilax

Type Brand
Pharm Class Osmotic Activity [MoA],
Osmotic Laxative [EPC],
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Active Ingredients
Polyethylene glycol 3350 17 g/17g
Route ORAL
Dosage Form POWDER, FOR SOLUTION
RxCUI drug identifier 876193,
876214
Application Number ANDA091077
Labeler Name Proficient Rx LP
Packages
Package NDC Code Description
63187-368-23 238 g in 1 bottle (63187-368-23)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Polyethylene Glycol 3350, 17 g (cap filled to line)

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.
Stop use and ask a doctor if • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. • you get diarrhea • you need to use a laxative for longer than 1 week If pregnant or breast-feeding, ask a health professional before use.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient none

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.
Directions • do not take more than directed unless advised by your doctor • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line. • adults and children 17 years of age and older: • fill to top of line in cap which is marked to indicate the correct dose (17 g) • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink • use once a day • use no more than 7 days • children 16 years of age or under: ask a doctor Other Information • store at 20°- 25°C (68°– 77°F) • tamper-evident: do not use if printed foil seal under cap is missing, open or broken

Purpose

Information about the drug product’s indications for use.
Purpose Osmotic Laxative Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days

Spl product data elements

Usually a list of ingredients in a drug product.
GAVILAX Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 SODIUM HYDROXIDE

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.PRINCIPAL DISPLAY PANEL NDC 63187-368-23 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative 14 ONCE-DAILY DOSES NET WT 8.3 OZ (238 g) Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 63187-368-23

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 • nausea, vomiting or abdominal pain • a sudden change in bowel habits that lasts over 2 weeks • irritable bowel syndrome Ask a doctor or pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools

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 the reach of children In case of overdose, get medical help or contact a POISON CONTROL CENTER right away. (1-800-222-1222)

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? 1-866-403-7592

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 Allergy alert: Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor

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