Label: SMOOTH LAX ORIGINAL PRESCRIPTION STRENGTH- polyethylene glycol 3350 powder, for solution
- NDC Code(s): 0363-0181-04
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each dose)
Polyethylene Glycol 3350, 17 g (in each level scoop)Close
- 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
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
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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- do not take more than directed unless advised by your doctor
- the enclosed scoop is a measuring device designed to contain 17 grams of powder when filled to the top (level scoop)
- adults and children 17 years of age and older:
- fill scoop completely with product to obtain the correct dose (17 g). Level scoop with knife or flat object.
- 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°-25°C (68°-77°F)
- tamper-evident: do not use if printed foil seal under cap is missing, open or broken
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
Compare to MiraLAX® or Dulcolax® Balance active ingredient
Original Prescription Strength
Polyethylene Glycol 3350
Powder for Solution, Laxative
This Package For Households Without Young Children
Relieves Occasional Constipation
# Once-Daily Doses
Smooth Lax(tm) Label
- INGREDIENTS AND APPEARANCE
SMOOTH LAX ORIGINAL PRESCRIPTION STRENGTH
polyethylene glycol 3350 powder, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0181 Route of Administration ORAL DEA Schedule 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 Product Characteristics Color WHITE (or almost whtie) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0181-04 850 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090685 10/08/2009 Labeler - Walgreen Company (008965063)