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NDC 61919-0497-71 LAXACIN 50; 8.6 mg/1; mg/1 Details
LAXACIN 50; 8.6 mg/1; mg/1
LAXACIN is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Direct_Rx. The primary component is DOCUSATE SODIUM; SENNOSIDES A AND B.
MedlinePlus Drug Summary
Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.
Related Packages: 61919-0497-71Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Senna
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: 61919-0497-71Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners
Product Information
NDC | 61919-0497 |
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Product ID | 61919-497_ea4e7175-945d-6be8-e053-2a95a90a507c |
Associated GPIs | 46991002770320 |
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 | LAXACIN |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | LAXACIN |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 50; 8.6 |
Active Ingredient Units | mg/1; mg/1 |
Substance Name | DOCUSATE SODIUM; SENNOSIDES A AND B |
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 61919-0497-71 (61919049771)
NDC Package Code | 61919-497-71 |
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Billing NDC | 61919049771 |
Package | 100 TABLET in 1 BOTTLE (61919-497-71) |
Marketing Start Date | 2019-08-28 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 912f7025-3bc7-3673-e053-2a95a90adbc2 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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Directions
•
take preferably at bedtime or as directed by a doctor
age
starting dose
maximum dose
adults and children 12
years and older
2 tablets once a day
4 tablets twice a day
children 6 to under 12 years
1 tablet once a day
2 tablets twice a day
children 2 to under 6 years
1/2 tablet once a day
1 tablet twice a day
children under 2 years
ask a doctor
ask a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
LAXACIN
laxacin tablet |
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Labeler - Direct_Rx (079254320) |
Registrant - Direct_Rx (079254320) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Direct_Rx | 079254320 | repack(61919-497) |