American Sales Company Clearlax®

American Sales Company Clearlax®
SPL v10
SPL
SPL Set ID c548c557-a88f-4fcc-a297-fc4219169299
Route
ORAL
Published
Effective Date 2023-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3350 (17 g)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2009-10-09 Until 2014-02-09
Description

Polyethylene Glycol 3350, 17 g (cap filled to line)

Purpose

Osmotic Laxative

Medication Information

Purpose

Osmotic Laxative

Description

Polyethylene Glycol 3350, 17 g (cap filled to line)

Use
  • •
    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

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:
  • •
    use once a day
  • •
    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
  • •
    do not combine with starch-based thickeners used for difficulty swallowing
  • •
    ensure that the powder is fully dissolved before drinking
  • •
    do not drink if there are any clumps
  • •
    do not use more than 7 days
  • •
    children 16 years of age or under: ask a doctor
Do Not Use

if you have kidney disease, except under the advice and supervision of 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

none

Questions Or Comments?

1-800-719-9260

Principal Display Panel

CAREone®

Compare to the active ingredient in MiraLAX®

CLEARLAX®

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative

Relieves Occasional Constipation/Irregularity

Softens Stool

Grit Free Unflavored Powder

30 ONCE-DAILY DOSES

Gluten Free

OUR PHARMACISTS RECOMMEND

NET WT 17.9 OZ (510g)

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 get diarrhea
  • •
    you need to use a laxative for longer than 1 week
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 (1-800-222-1222).

Active Ingredient (in Each Dose)

Polyethylene Glycol 3350, 17 g (cap filled to line)

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

Structured Label Content

Use
  • •
    relieves occasional constipation (irregularity)
  • •
    generally produces a bowel movement in 1 to 3 days
Purpose

Osmotic Laxative

Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol

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:
  • •
    use once a day
  • •
    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
  • •
    do not combine with starch-based thickeners used for difficulty swallowing
  • •
    ensure that the powder is fully dissolved before drinking
  • •
    do not drink if there are any clumps
  • •
    do not use more than 7 days
  • •
    children 16 years of age or under: ask a doctor
Do Not Use (Do not use)

if you have kidney disease, except under the advice and supervision of a doctor

Other Information (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 (Inactive ingredients)

none

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

CAREone®

Compare to the active ingredient in MiraLAX®

CLEARLAX®

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative

Relieves Occasional Constipation/Irregularity

Softens Stool

Grit Free Unflavored Powder

30 ONCE-DAILY DOSES

Gluten Free

OUR PHARMACISTS RECOMMEND

NET WT 17.9 OZ (510g)

When Using This Product (When using this product)

you may have loose, watery, more frequent stools

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Active Ingredient (in Each Dose) (Active ingredient (in each dose))

Polyethylene Glycol 3350, 17 g (cap filled to line)

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking a prescription drug

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:42.757204 · Updated: 2026-03-14T23:01:09.685872