POLYETHYLENE GLYCOL 3350

Emcure Pharmaceuticals USA Inc.

Drug FactsActive ingredient (in each dose)Polyethylene Glycol 3350, 17 g (cap filled to line)PurposeOsmotic Laxative

FULL PRESCRIBING INFORMATION: CONTENTS*

• INDICATIONS & USAGE
• WARNINGS
• DIRECTIONS
• Principal display panel

FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE

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

• nausea, vomiting or abdominal pain
• a sudden change in bowel habits that lasts over 2 weeks
• irritable bowel syndrome

• 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

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

• Relieves Occasional Constipation (Irregularity)
• Softens Stools

• Relieves Occasional Constipation (Irregularity)
• Softens Stools

•  relieves occasional constipation (irregularity)
• generally produces a bowel movement in 1 to 3 days

Do not use if you have kidney disease, except under the advice and supervision of a doctor

• 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

• 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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 

• 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 

• store at 20^o- 25 ^oC (68^o-77^o F)
• tamper- evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken