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NDC 61919-0879-51 POLYTHYLENE GLYCOL 17 g/17g Details
POLYTHYLENE GLYCOL 17 g/17g
POLYTHYLENE GLYCOL is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by DIRECT RX. 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: 61919-0879-51Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Polyethylene Glycol 3350
Product Information
| NDC | 61919-0879 |
|---|---|
| Product ID | 61919-879_9ab23521-8eec-5740-e053-2a95a90a1411 |
| Associated GPIs | 46600033002910 |
| 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 | POLYTHYLENE GLYCOL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | POLYTHYLENE GLYCOL |
| 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 | DIRECT RX |
| 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 61919-0879-51 (61919087951)
| NDC Package Code | 61919-879-51 |
|---|---|
| Billing NDC | 61919087951 |
| Package | 510 g in 1 BOTTLE (61919-879-51) |
| Marketing Start Date | 2019-07-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9ab23521-8eeb-5740-e053-2a95a90a1411 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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.
MEDICATION GUIDE
do not take more than directed unless advised by your doctor
This product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line.
adults and children 17 years of age and older:
fill to indicated "17 GRAMS" line on cup 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
use once a day
use no more than 7 days
children 16 years of age or younger: ask a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| POLYTHYLENE GLYCOL
polythylene glycol powder, for solution |
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| Labeler - DIRECT RX (079254320) |
| Registrant - DIRECT RX (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DIRECT RX | 079254320 | relabel(61919-879) | |