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| Product NDC Code | 11534-180 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | SUNRISE PHARMACEUTICAL, 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 (in each dose) 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.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 (clear section in cap) adults and children 17 years of age and older: ○ fill to top of clear section 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
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 11534- 180 -19 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Dissolves in Any Beverage Unflavored Powder Grit Free Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool. NDC 11534- 180 -28 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Dissolves in Any Beverage Unflavored Powder Grit Free Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool. NDC 11534- 180 -50 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Dissolves in Any Beverage Unflavored Powder Grit Free Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool. 2ffddd92-figure-01 2ffddd92-figure-02 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 foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, 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? 1-800-FDA-1088 Manufactured & Distributed by: Sunrise Pharmaceutical, Inc. Rahway, NJ 07065
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 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