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NDC 00363-0489-14 Smooth LAX 17 g/17g Details
Smooth LAX 17 g/17g
Smooth LAX is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREENS. The primary component is POLYETHYLENE GLYCOL 3350.
MedlinePlus Drug Summary
Polyethylene glycol 3350 is used to treat occasional constipation. Polyethylene glycol 3350 is in a class of medications called osmotic laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.
Related Packages: 00363-0489-14Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Polyethylene Glycol 3350
Product Information
| NDC | 00363-0489 |
|---|---|
| Product ID | 0363-0489_ee3ba77e-fd66-5f98-e053-2a95a90ac467 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Smooth LAX |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | polyethylene glycol 3350 |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | POWDER, FOR SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 17 |
| Active Ingredient Units | g/17g |
| Substance Name | POLYETHYLENE GLYCOL 3350 |
| Labeler Name | WALGREENS |
| Pharmaceutical Class | Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090812 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 00363-0489-14 (00363048914)
| NDC Package Code | 0363-0489-14 |
|---|---|
| Billing NDC | 00363048914 |
| Package | 238 g in 1 BOTTLE (0363-0489-14) |
| Marketing Start Date | 2020-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a1c3d04c-3b13-58bf-e053-2a95a90a7638 Details
Active ingredient (in each dose)
Use
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
- do not take more than directed unless advised by your doctor
- the bottle top is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
- adults and children 17 years of age and older:
- use once a day
- fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
- 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
Other information
INGREDIENTS AND APPEARANCE
| SMOOTH LAX
polyethylene glycol 3350 powder, for solution |
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| Labeler - WALGREENS (008965063) |
| Registrant - Geri-Care Pharmaceutical Corp (611196254) |