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| Product NDC Code | 59556-762 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ANDA203928 | ||||||||||||
| Labeler Name | Strides Pharma 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 ingedient (in each dose) (Can only) 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 (Can Only) 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 (white section in cap) adults and children 17 years of age and older: use once a day fill to top of white 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 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 Directions (Packet Only) do not take more than directed unless advised by your doctor adults and children 17 years of age and older: use once a day stir and dissolve one packet of powder (17 g) 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients 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.Active ingredient (in each dose) (Packet Only) Polyethylene Glycol 3350, 17 g
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 Colorless upon dissolution
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 10 Packets NDC 59556-762-01 Polyethylene Glycol 3350 Powder for Solution Osmotic Laxative Relieves Occasional Constipation (Irregularity) Softens Stool TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN Unflavored Sugar Free Dissolves in Any Beverage 10 ONCE-DAILY DOSES 10 PACKETS NET WT 0.5 OZ (17g) EACH 10s carton 10 packets in a carton
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 24 Packets NDC 59556-762-02 Polyethylene Glycol 3350 Powder for Solution Osmotic Laxative Relieves Occasional Constipation (Irregularity) Softens Stool TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN Unflavored Sugar Free Dissolves in Any Beverage 24 ONCE-DAILY DOSES 24 PACKETS NET WT 0.5 OZ (17g) EACH 24s carton 24 packets in a carton
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 59556-762-00 Original Prescription Strength Polyethylene Glycol 3350 Powder for Solution Osmotic Laxative Relieves Occasional Constipation (Irregularity) Softens Stool TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN Unflavored Sugar Free Dissolves in Any Beverage 1 DOSE NET WT 0.5 OZ (17 g) packet Packet
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 59556-762-03 Original Prescription Strength Polyethylene Glycol 3350 Powder for Solution Osmotic Laxative Relieves Occasional Constipation (Irregularity) Softens Stool TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN Unflavored Sugar Free Dissolves in Any Beverage 7 ONCE-DAILY DOSES NET WT 4.15 OZ (119 g) 119 g CAN - FRONT 119 g BACK [CAN] 119g BACK [CAN] 119g BACK [CAN] 119g BACK [CAN] 119 g CAN - FRONT 119 g BASE LABEL 119g BACK LABEL 119g BACK LABEL 119g BACK LABEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 59556-762-04 Original Prescription Strength Polyethylene Glycol 3350 Powder for Solution Osmotic Laxative Relieves Occasional Constipation (Irregularity) Softens Stool TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN Unflavored Sugar Free Dissolves in Any Beverage 14 ONCE-DAILY DOSES NET WT 8.3 OZ (238 g) 238 G CAN - FRONT 238 G CAN - BACK 238 G CAN - BACK 238 G FRONT LABEL 238g BACK LABEL CAN - BACK LABEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 59556-762-05 Original Prescription Strength Polyethylene Glycol 3350 Powder for Solution Osmotic Laxative Relieves Occasional Constipation (Irregularity) Softens Stool TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN Unflavored Sugar Free Dissolves in Any Beverage 30 ONCE-DAILY DOSES NET WT 17.9 OZ (510 g) 510 g CAN - FRONT 510 g CAN - BACK 510 g FRONT LABEL CAN - BACK
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.Polyethylene Glycol 3350, Powder for Solution Drug Facts
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.Purpose Osmotic Laxative
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 the 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? 1-877-244-9825 Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool. Manufactured by: Strides Pharma Science Limited Bengaluru – 5562106, India. Distributed by Strides Pharma Inc. East Brunswick, NJ 08816
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 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 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. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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