Polyethylene Glycol
PronunciationGeneric Name: Polyethylene Glycol 3350
Dosage Form: powder, for oral solution
Drug Facts
Active ingredient (in each dose)
Polyethylene Glycol 3350, 17 g (cap filled to line)
Purpose
Osmotic Laxative
INDICATIONS & USAGE
Use
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 1 to 3 days
Warnings
Allergy alert:
Grapefruit and grapefruit juice can react adversely with over 85 prescription medications.
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 of 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 or 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
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088
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.
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:
- fill to top of white section in cap which is marked to indicate the correct dose (17g)
- 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
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
Principal display panel
Base panel
Polyethylene Glycol 3350 NF
Powder for Solution, Osmotic Laxative
- Relieves Occasional Constipation (Irregularity)
- Softens Stools
NDC 14539-150-20
Original Prescription Strength
Dissolves in Any Beverage
30 ONCE-DAILY DOSES
Net Wt. 510 g
Polyethylene Glycol 3350 NF increases frequency of bowel movements and softens the stools.
Manufactured By:
Emcure Pharmaceuticals USA Inc.
21/B Cotters Lane
East Brunswick, NJ 08816, USA.
Top panel
Polyethylene Glycol 3350 NF
Powder for Solution, Osmotic Laxative
- Relieves Occasional Constipation (Irregularity)
- Softens Stools
NDC 14539-150-20
PEEL HERE
Original Prescription Strength
30 ONCE-DAILY DOSES
Net Wt. 510 g
Drug Facts
Active ingredient (in each dose) Purpose
Polyethylene Glycol 3350,
17 g (cap filled to line).............Osmotic Laxative
Use
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 1 to 3 days
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
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088
If Pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. 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:
- fill to top of white section in cap which is marked to indicate the correct dose (17g)
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- use once a day
- use not more than 7 days
- children 16 years of age or under: ask a doctor
Other information
- store at 20o- 25 oC (68o-77o 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

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| Labeler - Emcure Pharmaceuticals USA Inc. (189630168) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Emcure Pharmaceuticals USA Inc. | 189630168 | ANALYSIS(14539-150), MANUFACTURE(14539-150) | |


