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Product NDC Code | 69784-180 | ||||||||
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Drug Name | Polyethylene glycol 3350 nf |
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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 | ||||||||
Application Number | ANDA206105 | ||||||||
Labeler Name | Woodward Pharma Services LLC | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Polyethylene Glycol 3350, 17 g
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 adults and children 17 years of age and older: ○ stir and dissolve one packet 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
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.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 NF 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.PRINCIPAL DISPLAY PANEL NDC 69784-180-01 Compare to MiraLAX® Original Prescription Strength PEG3350 Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative Relieves Occasional Constipation (irregularity) Softens Stool NET WT 0.5 OZ (17gm) 1 DOSE 2ffddd92-figure-03
PRINCIPAL DISPLAY PANEL NDC 69784-180-14 Compare to MiraLAX® Original Prescription Strength PEG3350 Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative Relieves Occasional Constipation (irregularity) Softens Stool 14 ct Unit-Dose Packets 0.5 OZ (17 gm) each 2ffddd92-figure-03
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.Drug Facts
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
Other information store at 20° - 25°C (68° - 77°F) tamper- evident: do not use if printed foil pouch is open or broken
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 doctor or pharmacist before use if you are taking a prescription drug
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.
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? 1-888-514-4727
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.
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