Active Ingredients And Purpose
Active Ingredient
Polyethylene Glycol 3350, 17 g (cap filled to line)
Purpose
Osmotic Laxative Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
CLEARLAX- polyethylene glycol 3350 powder, for solution
- Manufacturer
- Wal-Mart Stores, Inc. | Novel Laboratories, Inc.
- Effective date
- 2018-06-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:55:59
Key Label Information#
Uses
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 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
Warnings
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.
Directions And Dosage
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.
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 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
Other Label Information
Inactive Ingredient
none
Questions or comments?
1-866-403-7592
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 49035-316-08 Original Prescription Strength ClearLax Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative 14 ONCE-DAILY DOSES NET WT 8.3 OZ (238 g) NDC 49035-316-07 Original Prescription Strength ClearLax Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative 7 ONCE-DAILY DOSES NET WT 4.1 OZ (119 g)
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 880407 | ClearLax 17 GM Powder for Oral Solution | PSN | 1 |
| 876193 | polyethylene glycol 3350 17 GM Powder for Oral Solution | PSN | 1 |
| 880407 | polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax] | SBD | 1 |
| 876193 | polyethylene glycol 3350 17000 MG Powder for Oral Solution | SCD | 1 |
| 880407 | ClearLax 17 GM Powder for Oral Solution | SY | 1 |
| 876193 | polyethylene glycol 3350 17 GM Powder for Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| POLYETHYLENE GLYCOL 3350 Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49035-316-07 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d579-f424-e053-dadaa90a57ce | CLEARLAX- polyethylene glycol 3350 powder, for solution |
| 49035-316-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d579-f424-e053-dadaa90a57ce | CLEARLAX- polyethylene glycol 3350 powder, for solution |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-316-07 | ClearLax | 119 g in 1 BOTTLE | POWDER, FOR SOLUTION | 119 | 1 | |
| 49035-316-08 | ClearLax | 238 g in 1 BOTTLE | POWDER, FOR SOLUTION | 238 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
- ClearLax
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49035-316 | 49035-316-07, 49035-316-08 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | ACTIB |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
Complete SPL Sections#
Active Ingredient
Polyethylene Glycol 3350, 17 g (cap filled to line)
Purpose
Osmotic Laxative 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 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 the reach of children
In case of overdose, get medical help or contact a POISON CONTROL CENTER right away. (1-800-222-1222)
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 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 Ingredient
none
Questions or comments?
1-866-403-7592
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 49035-316-08 Original Prescription Strength ClearLax Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative 14 ONCE-DAILY DOSES NET WT 8.3 OZ (238 g) NDC 49035-316-07 Original Prescription Strength ClearLax Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative 7 ONCE-DAILY DOSES NET WT 4.1 OZ (119 g)