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NDC 72189-0195-71 STOOL SOFTENER 100 mg/1 Details
STOOL SOFTENER 100 mg/1
STOOL SOFTENER is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by DIRECT RX. The primary component is DOCUSATE SODIUM.
MedlinePlus Drug Summary
Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.
Related Packages: 72189-0195-71Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners
Product Information
NDC | 72189-0195 |
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Product ID | 72189-195_c10aab76-65c1-48e2-e053-2a95a90a9461 |
Associated GPIs | 46500010300110 |
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 | STOOL SOFTENER |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | docusate sodium |
Product Type | HUMAN OTC DRUG |
Dosage Form | CAPSULE, LIQUID FILLED |
Route | ORAL |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/1 |
Substance Name | DOCUSATE SODIUM |
Labeler Name | DIRECT RX |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part334 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 72189-0195-71 (72189019571)
NDC Package Code | 72189-195-71 |
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Billing NDC | 72189019571 |
Package | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (72189-195-71) |
Marketing Start Date | 2021-03-30 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bec3450e-73fe-d223-e053-2a95a90afc00 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Ask a doctor before use if you
• have stomach pain, nausea or vomiting
• have a sudden change in bowel habits that persists over a period of 2 weeks
• are presently taking mineral oil
Stop use and ask a doctor if
• you need to use a laxative longer than 1 week
• you have rectal bleeding or fail to have a bowel movement. These
could be signs of a serious condition.
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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
STOOL SOFTENER
docusate sodium capsule, liquid filled |
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Labeler - DIRECT RX (079254320) |
Registrant - DIRECT RX (079254320) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
DIRECT RX | 079254320 | relabel(72189-195) |