RxNorm Names
Review RxNorm Normal Forms
GAVILAX
(polyethylene glycol-3350)
powder, for solution
[GAVIS Pharmaceuticals, LLC]
DESCRIPTION
Drug Facts
Active Ingredient (in each dose)………………… Purpose
Polyethylene Glycol 3350, 17 g (cap filled to line).......Laxative
Use
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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
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
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side effects occur.
Drug Facts (continued)
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
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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 Ingredients none
Questions or comments?
1-866-403-7592
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
| GAVILAX
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 | 10/09/2009 | |
| Labeler - GAVIS Pharmaceuticals, LLC (829838551) | |||||||||
| Contact | Address | Telephone Number | Email Address | ||||||
| Anu Radha Subramanian |
| ++1908-603-6080 | ars@gavispharma.com | ||||||
| Registrant - Novel Laboratories, Inc. (793518643) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Novel Laboratories, Inc. | 793518643 | manufacture, repack, MANUFACTURE, ANALYSIS, ANALYSIS | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Dow Chemical Company | 801038019 | api manufacture, MANUFACTURE | |
