RxNorm Names
Review RxNorm Normal Forms
POLYETHYLENE GLYCOL-3350 powder, for solution
[Novel Laboratories, Inc.]
Drug Facts
OTC - ACTIVE INGREDIENT
Active Ingredient (in each dose)..........................................Purpose
Polyethylene Glycol 3350, 17 g (cap filled to line).....................Laxative
Use
-
relieves occasional constipation (irregularity)
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generally produces a bowel movement in 1 to 3 days
WARNINGS
Allergy alert: Do not use if you are allergic to polyethylene glycol
OTC - DO NOT USE
Do not use if you have kidney disease, except under the advice and supervision of a doctor
OTC - ASK 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
OTC - ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are taking a prescription drug
OTC - WHEN USING
When using this product you may have loose, watery, more frequent stools
OTC - STOP USE
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
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side effects occur. You may report side effects to FDA at 1-800-FDA-1088
Drug Facts (continued)
OTC - PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help or contact a POISON CONTROL CENTER right away.
Directions
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do not take more than directed unless advised by your doctor
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the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line.
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adults and children 17 years of age and older:
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fill to top of line in cap which is marked to indicate 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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use once a day
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use no more than 7 days
-
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children 16 years of age or under: ask a doctor
Other Information
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store at 20° - 25°C (68°– 77°F)
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tamper-evident: do not use if printed foil seal under cap is missing, open or broken
INACTIVE INGREDIENT
Inactive Ingredients none
OTC - QUESTIONS
Questions or comments?
1-800-FDA-1088 (1-800-332-1088) or www.fda.gov
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
| POLYETHYLENE GLYCOL-3350
polyethylene glycol-3350 powder, for solution |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA091077 | 10/06/2009 | |
| Labeler - Novel Laboratories, Inc. (793518643) | |||||||||
| Contact | Address | Telephone Number | Email Address | ||||||
| Anu Radha Subramanian |
| ++1908-603-6000;ext=6002 | ars@novellabs.net | ||||||
| Registrant - Novel Laboratories, Inc. (793518643) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Novel Laboratories, Inc. | 793518643 | MANUFACTURE, ANALYSIS, repack | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Dow Chemical Company | 801038019 | api manufacture | |
