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| Product NDC Code | 43386-312 | ||||||
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| Drug Name | Gavilax |
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| Type | Brand | ||||||
| Pharm Class | 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 | POWDER, FOR SOLUTION | ||||||
| RxCUI drug identifier | 876193, 876214 |
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| Application Number | ANDA091077 | ||||||
| Labeler Name | Lupin Pharmaceuticals,Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Polyethylene Glycol 3350, 17 g (cap filled to line)……………………Osmotic Laxative
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: use once a day 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 do not combine with starch-based thickeners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do not drink if there are any clumps do not use 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, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Purpose
Information about the drug product’s indications for use.Purpose 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 43386-312-08 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 14 ONCE-DAILY DOSES NET WT 8.3 OZ (238 g) NDC 43386-312-85 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 50 ONCE-DAILY DOSES NET WT 29.9 OZ (850 g) NDC 43386-312-07 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 7 ONCE-DAILY DOSES NET WT 4.1 OZ (119 g) NDC 43386-312-14 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 30 ONCE-DAILY DOSES NET WT 17.9 OZ (510 g) 238g Drug facts- back 850 g 4.1 oz 17.9 oz
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 Dissolves in any beverages Sugar Free
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