POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE powder, for solution

Polyethylene Glycol 3350, NF Powder for Solution, Laxative by

Drug Labeling and Warnings

Polyethylene Glycol 3350, NF Powder for Solution, Laxative by is a Otc medication manufactured, distributed, or labeled by Nexgen Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Label Principal Display Panel

9 oz Container Label

Label Principal Display Panel

4.1 oz Container Label - Drug Facts on Extended Content Label

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE 
polyethylene glycol 3350, nf powder for solution, laxative powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0722-7116
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g  in 1 d

Product Characteristics
Color	WHITE (colorless upon dissolution)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0722-7116-01	7 d in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2009
2	NDC: 0722-7116-02	14 d in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2009
3	NDC: 0722-7116-03	30 d in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090812	10/07/2009

Labeler - Nexgen Pharma, Inc. (048488621)

Registrant - Nexgen Pharma, Inc. (048488621)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		160356114	ANALYSIS(0722-7116) , LABEL(0722-7116) , MANUFACTURE(0722-7116) , PACK(0722-7116)