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| Product NDC Code | 58602-805 | ||||||||||||||
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| Drug Name | Polyethylene glycol 3350 |
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| Type | Generic | ||||||||||||||
| 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 | ||||||||||||||
| Application Number | ANDA209017 | ||||||||||||||
| Labeler Name | Aurohealth LLC | ||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each dose) Polyethylene Glycol 3350, USP 17 grams (cup filled to the indicated 17 grams 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.Directions do not take more than directed unless advised by your doctor this product is supplied with a dosing cup 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 the indicated 17 grams line on cup which is marked to indicate the correct dose 17 grams 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 no more than 7 days children 16 years of age or under: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients none Questions or comments? call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/19/1993
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.Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
Purpose
Information about the drug product’s indications for use.Purpose Osmotic Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Polyethylene Glycol 3350 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350
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 - 119 g Bottle Label AUROHEALTH NDC 58602-805-01 Compare to active ingredient of MiraLax ® * Polyethylene Glycol 3350 Powder for Oral Solution Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool UNFLAVORED POWDER - GRIT FREE 7 ONCE-DAILY DOSES NET WT 4.1 OZ (119 g) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Label AUROHEALTH NDC 58602-805-26 Compare to active ingredient of MiraLax ® * Polyethylene Glycol 3350 Powder for Oral Solution Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Sugar Free Dissolves in any Beverage UNFLAVORED POWDER - GRIT FREE 1 DOSE NET WT 0.5 oz (17 g) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Carton Label
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Carton Label AUROHEALTH NDC 58602-805-27 Compare to active ingredient of MiraLax ® * Polyethylene Glycol 3350 Powder for Oral Solution Osmotic Laxative Polyethylene Glycol 3350 powder for oral solution increases frequency of bowel movements and softness the stool. Relieves Occasional Constipation/Irregularity Softens Stool Sugar Free Dissolves in Any Beverage 14 ONCE-DAILY DOSES UNFLAVORED POWDER - GRIT FREE 14 PRE-MEASURED, SINGLE DOSES 14 Packets NET WT 0.5 oz (17 g) Each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Label
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 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 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 if you have kidney disease, except under the advice and supervision of 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.
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 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
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 you may have loose, watery, more frequent stools
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20° to 25°C (68° to 77°F) tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
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
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