FDA Label for Polyethylene Glycol
View Indications, Usage & Precautions
Polyethylene Glycol Product Label
The following document was submitted to the FDA by the labeler of this product Harmon Stores, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Active Ingredient (In Each Dose)
Polyethylene Glycol 3350, 17 g (cap filled to line)
Purpose
Osmotic Laxative
Use
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 1 to 3 days
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
- When using this product you may have loose, watery, more frequent stools
Ask a doctor of pharmacist before use if you are taking a prescription drug
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 top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
- adults and children 17 years of age and older:
- fill to top of white section in cap which is marked to indicate the correct dose (17 g)
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- use once a day
- use no more than 7 days
- children 16 years of age or under: ask a doctor
Other Information
- store at 20° to 25°C (68° to 77°F)
- tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Inactive Ingredient
none
Questions Or Comments?
1-877-753-3935
Made in India
*Miralax® is a registered trademark of Bayer Consumer Care Holdings LLC
Distributed by Liberty
Procurement, Inc.650 Liberty
Ave. Union, NJ 07083 USA
Visit us at: www.facevalues.com
Revised: 01/2017
Package Label.Principal Display Panel
NDC 63940-762-03
Polyethylene Glycol 3350
Powder for Solution
OSMOTIC LAXATIVE
Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
- Dissolves in any beverage
- Sugar Free
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
- Dissolves in any beverage
- Sugar Free
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
- Dissolves in any beverage
- Sugar Free
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
7 Once-Daily Doses
NET WT 4.15 OZ (119 g)
NDC 63940-762-04
Polyethylene Glycol 3350
Powder for Solution
OSMOTIC LAXATIVE
Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
14 Once-Daily Doses
NET WT 8.3 OZ (238 g)
NDC 63940-762-05
Polyethylene Glycol 3350
Powder for Solution
OSMOTIC LAXATIVE
Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
30 Once-Daily Doses
NET WT 17.9 OZ (510 g)
* Please review the disclaimer below.