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NDC 54859-0813-16 Docusate Sodium Liquid 50 mg/5mL Details
Docusate Sodium Liquid 50 mg/5mL
Docusate Sodium Liquid is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. 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: 54859-0813-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners
Product Information
| NDC | 54859-0813 |
|---|---|
| Product ID | 54859-813_0a7003c3-ab45-4797-8b98-44dba7314f33 |
| Associated GPIs | |
| GCN Sequence Number | 003017 |
| GCN Sequence Number Description | docusate sodium LIQUID 50 MG/5 ML ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 09131 |
| HICL Sequence Number | 001326 |
| HICL Sequence Number Description | DOCUSATE SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Docusate Sodium Liquid |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Docusate Sodium |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/5mL |
| Substance Name | DOCUSATE SODIUM |
| Labeler Name | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 54859-0813-16 (54859081316)
| NDC Package Code | 54859-813-16 |
|---|---|
| Billing NDC | 54859081316 |
| Package | 473 mL in 1 BOTTLE (54859-813-16) |
| Marketing Start Date | 2021-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c Details
SPL UNCLASSIFIED SECTION
Warnings
Do not use when
- abdominal pain, nausea, or vomiting are present unless directed by a doctor
- for more than one week unless directed by a doctor
Ask a doctore before use if you
- are taking mineral oil
- have noticed a sudden change in bowel habits that last more than two weeks
Stop use and ask doctor if
- you have no bowel movements within 3 days
- you have rectal bleeding
- these could be signs of a serious condition
- a skin rash occurs
- you experience throat irritation
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
- follow dosing directions below or use as directed by a physician
- must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation
- may be taken as a single daily dose or in dividend dose
- take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
- do not exceed recommended dose
- shake well before using
1 teasponnful = 5 mL
| Age | Dose |
| Adults and children over 12 years of age | 1 to 6 teaspoons (50 mg - 300 mg) |
| Children under 12 years of age | Ask a doctor |
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| DOCUSATE SODIUM LIQUID
docusate sodium liquid |
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| Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305) |
Revised: 12/2021
Document Id: 0a7003c3-ab45-4797-8b98-44dba7314f33
Set id: 2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c
Version: 1
Effective Time: 20211212