FDA Label for Polyethylene Glycol 3350
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH DOSE)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Polyethylene Glycol 3350 Product Label
The following document was submitted to the FDA by the labeler of this product Discount Drug Mart. 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.
Active Ingredient (In Each Dose)
Polyethylene Glycol 3350,
17 grams (cap filled to the indicated “17 GRAMS” line)
Purpose
Laxative
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 need to use a laxative for longer than 1 week
- you get diarrhea
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
- do not take more than directed unless advised by your doctor
- the bottle cap is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
- adults and children 17 years of age and older:
- fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
- 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
- fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
- children 16 years of age or younger: ask a doctor
Other Information
- store at 20°-25°C (68°-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?
1-800-426-9391
Principal Display Panel
Discount
Drug
Mart
Food Fair
NDC 53943-742-90
ORIGINAL PRESCRIPTION STRENGTH
Polyethylene
Glycol 3350
Powder For Solution Osmotic Laxative
Relieves occasional constipation (irregularity)
and softens stool
• Sugar Free
• Dissolves in any beverage
*Compare to the active ingredient in MiraLAX®
NET WT 17.9 OZ (510 g)
UNFLAVORED POWDER
30 ONCE-DAILY DOSES
SATISFACTION GUARANTEED IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME,
ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART 211 COMMERCE DRIVE, MEDINA, OHIO 44256
DISTRIBUTED BY: DRUG MART - FOOD FAIR
211 COMMERCE DRIVE
MEDINA, OH 44256
www.discount-drugmart.com
Polyethylene Glycol 3350 increases the frequency
of bowel movements and softens the stool
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
*This product is not manufactured or distributed
by Bayer HealthCare LLC, owner of the registered
trademark MiraLAX®.
50844 ORG061974290
* Please review the disclaimer below.