POLYETHYLENE GLYCOL 3350 - polyethylene glycol 3350 powder, for solution 
CHAIN DRUG MARKETING ASSOCIATION, INC.

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Polyethylene Glycol 3350 Powder for Oral Solution, 17 g

Active ingredient (in each dose)



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



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

 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

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 1-888-375-3784

PRINCIPAL DISPLAY PANEL

Polyethylene glycol 3350 powder for oral solution bottle label 238g

polyethleneglcollabel1

Polyethylene glycol 3350 powder for oral solution bottle label 510g

polyethleneglcollabel2

POLYETHYLENE GLYCOL 3350  
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-002
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:83324-002-08238 g in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
2NDC:83324-002-16510 g in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21499003/01/2024
Labeler - CHAIN DRUG MARKETING ASSOCIATION, INC. (011920774)
Establishment
NameAddressID/FEIBusiness Operations
Annora Pharma Private Limited650980746analysis(83324-002) , manufacture(83324-002)

Revised: 3/2024
Document Id: 148df422-86ec-3bae-e063-6394a90a364e
Set id: 901a1918-87bb-47c2-a465-8c468c3a1ee5
Version: 1
Effective Time: 20240326
 
CHAIN DRUG MARKETING ASSOCIATION, INC.