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signature care clearlax

polyethylene glycol 3350 · signature care clearlax is an osmotic laxative (over-the-counter) containing polyethylene glycol 3350, made by Safeway.

Type
Over the counter
Drug class
Osmotic Laxative
Route
Oral
Manufacturers
1

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

Drug facts

Generic name
polyethylene glycol 3350
Active ingredients
Polyethylene Glycol 3350
How it works
Osmotic Activity
Dosage forms
Powder, for solution
Label holder
Safeway
FDA application
ANDA090685
Label updated
05/13/2021

Active ingredients

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

Purpose

Osmotic Laxative

Uses

  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement in 1 to 3 days

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

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 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).

Do not use

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

Ask a doctor before use

  • 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

Taking a prescription drug

When using this product

You may have loose, watery, more frequent stools

Stop use and ask a doctor

  • 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

Pregnancy or breastfeeding

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).

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

Inactive ingredients

None

Questions?

1-800-719-9260

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Powder, for solution17 g/17goral1

Manufacturers and labels

1 FDA label

  • SafewayShown hereANDA090685 · Label 05/13/2021 · NDC 21130-847Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

signature care clearlax: common questions

What is signature care clearlax used for?
• relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days
Is signature care clearlax a prescription drug?
No. signature care clearlax is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as signature care clearlax?
Yes. Other FDA-listed products with the same active ingredients include Clearlax, Polyethylene Glycol 3350, Nf Powder for Solution, Laxative, clear lax, dg health clearlax.
Who makes signature care clearlax?
Safeway lists signature care clearlax with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 05/13/2021 · Label text is shown as published by the manufacturer. Not medical advice