Checked
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
- Drug class
- Osmotic Laxative
- 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 form | Strength | Route | NDCs |
|---|---|---|---|
| Powder, for solution | 17 g/17g | oral | 1 |
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
- Class IIDrug08/17/2022Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT...Mckesson Medical-Surgical Inc. Corporate Office · CGMP Deviations: products were stored outside the drug label...
- Class IIDrug05/25/2022GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack...Lupin Pharmaceuticals Inc. · Failed Stability Specification
- Class IIDrug06/02/2021Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC...Cardinal Health Inc. · 2 products · CGMP Deviations: Intermittent exposure to temperature excursion...
- Class IIIDrug07/11/2018Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a)...LUPIN SOMERSET · Labeling: Not Elsewhere Classified - A private label distributor...
- Class IIDrug05/16/2018Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57Kroger Specialty Pharmacy, Inc. · Lack of Processing Controls.
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