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Drug Facts
Polyethylene Glycol 3350 Powder, For Solution
FDA Label NDC 57896-490
17 label sections · Submitted to the FDA by Gericare Pharmaceuticals · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gericare Pharmaceuticals for the product Polyethylene Glycol 3350 (NDC 57896-490). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each dose), purpose, use, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Dose)
Polyethylene Glycol 3350, 17 grams (cap filled to the indicated line)
Purpose
Osmotic Laxative
Use
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 1 to 3 days
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 Reach Of Childreen
In case of overdose, get medical help or contact a Poison Control Center right away.
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 (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 the 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 foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Inactive Ingredients
none
Otc - Questions
Questions or comments?
1-800-540-3765
Manufactured for:
Geri-Care Pharmaceuticals
1295 Townbin Ave. Lakewood, NJ 08701
Product of India
Issued: 07/2022
Package Label.Principal Display Panel
Original
Prescription
Strength
Polyethylene Glycol 3350
Powder for Solution
Osmotic Laxative
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
- Dissolves in any beverage
- Sugar Free
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
NDC 57896-490-01
1 DOSE
NET WT 0.5 OZ (17 g)
17g Sachet (F0c44850 Fe07 4c48 Bb9c Ded2c7fb822b 01)
NDC 57896-490-03
30 PACKETS
NET WT 0.5 OZ (17 g) Each
30s Carton (F0c44850 Fe07 4c48 Bb9c Ded2c7fb822b 02)
NDC 57896-490-07
7 ONCE-DAILY DOSES
NET WT 4.15 OZ (119 g)
119g Bottle (F0c44850 Fe07 4c48 Bb9c Ded2c7fb822b 03)
NDC 57896-490-14
14 ONCE-DAILY DOSES
NET WT 8.3 OZ (238 g)
238g Bottle (F0c44850 Fe07 4c48 Bb9c Ded2c7fb822b 04)
NDC 57896-490-30
30 ONCE-DAILY DOSES
NET WT 17.9 OZ (510 g)
510g (F0c44850 Fe07 4c48 Bb9c Ded2c7fb822b 05)
NDC 57896-490-45
45 ONCE-DAILY DOSES
NET WT 26.9 OZ (765 g)
765g Bottle (F0c44850 Fe07 4c48 Bb9c Ded2c7fb822b 06)
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