POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE- polyethylene glycol 3350, nf powder for solution, laxative powder, for solution 
Nexgen Pharma, Inc.

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Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 grams (cap filled to the top)

Purpose

Osmotic Laxative

Keep Out of Reach of Children

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

Uses

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.

Directions

Do not take more than directed unless advised by your doctor.
The bottle cap is a measuring cup designed to contain 17 grams of powder when filled to the top rim.
Adults and children 17 years of age and older:
Fill to the top of the bottle cap which will provide the correct dose (17 g).
Stir and dissolve in any 4 to 8 ounces of beverage (cold, hot, or room temperature), then drink.
Ensure that the powder is fully dissolved before drinking.
Do not drink if there are any clumps.
Use once a day.
Use no more than 7 days.

Children 16 years of age or younger, ask a doctor.

Other Information

Store at 20°C – 25°C (68°F – 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?

For serious adverse events call Nexgen Pharma, Inc. at 1-888-710-0006 or contact online at www.nexgenpharma.com.

Manufactured by: Nexgen Pharma, Inc., Irvine, CA 92606, USA

Rev. 09/2019

Label Principal Display Panel

17.9 oz Container Label

17.9 oz (510 g) Container Label

Label Principal Display Panel

9 oz Container Label

9 oz (238 g) Container Label

Label Principal Display Panel

4.1 oz Container Label - Drug Facts on Extended Content Label

4.1 oz Container Label - Drug Facts on Extended Content Label
POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE 
polyethylene glycol 3350, nf powder for solution, laxative powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0722-7116
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 1 d
Product Characteristics
ColorWHITE (colorless upon dissolution) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0722-7116-017 d in 1 BOTTLE; Type 0: Not a Combination Product10/07/2009
2NDC:0722-7116-0214 d in 1 BOTTLE; Type 0: Not a Combination Product10/07/2009
3NDC:0722-7116-0330 d in 1 BOTTLE; Type 0: Not a Combination Product10/07/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081210/07/2009
Labeler - Nexgen Pharma, Inc. (048488621)
Registrant - Nexgen Pharma, Inc. (048488621)
Establishment
NameAddressID/FEIBusiness Operations
Nexgen Pharma, Inc.160356114ANALYSIS(0722-7116) , LABEL(0722-7116) , MANUFACTURE(0722-7116) , PACK(0722-7116)

Revised: 9/2019
Document Id: 1004c7e3-4b55-456a-b2ab-bd14242769c9
Set id: d6218f65-1b41-417e-b928-56ac6db411af
Version: 2
Effective Time: 20190904
 
Nexgen Pharma, Inc.