Label: POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE powder, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 0722-7116-01, 0722-7116-02, 0722-7116-03 - Packager: Nexgen Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 4, 2019
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- Active ingredient (in each dose)
- Purpose
- Keep Out of Reach of Children
- Uses
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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:
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- nausea, vomiting or abdominal pain.
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- a sudden change in bowel habits that lasts over 2 weeks.
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- 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:
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- you have rectal bleeding, or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.
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- you get diarrhea.
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- you need to use a laxative for longer than 1 week.
If pregnant or breast-feeding, ask a health professional before use.
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Directions
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- Do not take more than directed unless advised by your doctor.
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- The bottle cap is a measuring cup designed to contain 17 grams of powder when filled to the top rim.
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- Adults and children 17 years of age and older:
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- Fill to the top of the bottle cap which will provide the correct dose (17 g).
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- Stir and dissolve in any 4 to 8 ounces of beverage (cold, hot, or room temperature), then drink.
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- Ensure that the powder is fully dissolved before drinking.
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- Do not drink if there are any clumps.
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- Use once a day.
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- Use no more than 7 days.
Children 16 years of age or younger, ask a doctor.
- Other Information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE
polyethylene glycol 3350, nf powder for solution, laxative powder, for solutionProduct 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)
