Label: SMOOTH LAX- polyethylene glycol powder
- NDC Code(s): 0363-0465-17, 0363-0465-26, 0363-0465-41, 0363-0465-83
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 10, 2015
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- Official Label (Printer Friendly)
- Active ingredient (in each dose)
- Purpose
- Uses
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Warnings
Allergy alert: Do not use if you are allergic to polyethylene glycol.
Ask a doctor before use if you have
- nausea, vomitting or abdominal pain
- a sudden change in bowel habits that lasts over 2 weeks
- irritable bowel syndrome
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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
- adults and children 17 years of age and older:
- fill to top of line in cap which is marked to indicate the correct dose (17 g)
- stir and dissolve in any 4 to 8 ounce 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
- Inactive ingredient
- Questions or comments?
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Principal Display Panel
Smooth LAX®
Polyethylene Glycol 3350
Powder for Oral Solution,
Osmotic Laxative
- Relieves occasional constipation / irregularity
- Softens stool
- Unflavored powder
- Grit free
FL OZ (mL)
Compare to MiraLAX® active ingredient≠≠
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Polyethylene glycol 3350 increases frequency of bowel movements and softens the stool
≠≠This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of MiraLAX®.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
- Package Label
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INGREDIENTS AND APPEARANCE
SMOOTH LAX
polyethylene glycol powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0465 Route of Administration TOPICAL 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 17 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0465-17 510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:0363-0465-26 765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:0363-0465-41 119 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:0363-0465-83 238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091077 08/31/2015 Labeler - Walgreens (008965063)