POLYETHYLENE GLYCOL 3350 - polyethylene glycol 3350 powder, for solution 
Camber Consumer Care Inc

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Polyethylene Glycol 3350 Powder for Oral Solution, 17 g

ACTIVE INGREDIENT (IN EACH DOSE)


(Bottle Only)            


Polyethylene Glycol 3350, 17 g (cap filled to line)


(Packet Only)            


Polyethylene Glycol 3350, 17 g 



PURPOSE

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


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

(Bottle 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 difficult 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

  (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 difficult 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° to 25°C (68° to 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

QUESTIONS OR COMMENTS?

call 1-888-588-1418.

PRINCIPAL DISPLAY PANEL

Polyethylene glycol 3350 powder for oral solution bottle label

 

bottlelabelfront

bottlebacklabel

Polyethylene glycol 3350 powder for oral solution carton label

cartonlabel

POLYETHYLENE GLYCOL 3350  
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-324
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69230-324-327 in 1 CARTON04/14/2021
117 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:69230-324-3310 in 1 CARTON04/14/2021
217 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:69230-324-34119 g in 1 BOTTLE; Type 0: Not a Combination Product04/14/2021
4NDC:69230-324-35238 g in 1 BOTTLE; Type 0: Not a Combination Product04/14/2021
5NDC:69230-324-36510 g in 1 BOTTLE; Type 0: Not a Combination Product04/14/2021
6NDC:69230-324-3714 in 1 CARTON04/14/2021
617 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21499004/14/2021
Labeler - Camber Consumer Care Inc (079539968)
Establishment
NameAddressID/FEIBusiness Operations
Annora Pharma Private Limited650980746manufacture(69230-324)

Revised: 3/2023
Document Id: f638e43b-0a1c-1a5d-e053-2a95a90a4caf
Set id: b321a7f5-f80b-4a51-9fd9-2c21fc1cae9b
Version: 5
Effective Time: 20230306
 
Camber Consumer Care Inc