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NDC 57896-0413-16 GeriCare Docusate Sodium Liquid 50 mg/5mL Details
GeriCare Docusate Sodium Liquid 50 mg/5mL
GeriCare Docusate Sodium Liquid is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by GERI-CARE PHARMACEUTICALS, CORP. 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: 57896-0413-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners
Product Information
| NDC | 57896-0413 |
|---|---|
| Product ID | 57896-413_cafb91c4-38df-40cd-b5fa-9afaa395affe |
| Associated GPIs | 46500010300910 |
| 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 | GeriCare 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 | GERI-CARE PHARMACEUTICALS, CORP |
| 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 57896-0413-16 (57896041316)
| NDC Package Code | 57896-413-16 |
|---|---|
| Billing NDC | 57896041316 |
| Package | 473 mL in 1 BOTTLE (57896-413-16) |
| Marketing Start Date | 2020-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e50558e1-f0c8-4b03-9109-6a273b61730d Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Do not use for more than one week unless directed by a doctor.
Ask a doctore before use if you
- have stomach pain, nausea or vomiting
- hadve sudden change in bowel habits that persits over a period of 2 weeks
- are taking mineral oil
Stop use and ask doctor if
- you have rectal bleeding or fail to have a bowel movement afrer use of this product. These could be signs of a serious condition.
- a skin rash occurs
- you experience throat irritation
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
shake well before using
- follow dosing directions below or use as directed by a physician
- do not exceed recommended dose
- 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
1 teasponnful = 5 mL
| Age | Dose |
| Adults and children over 12 years of age | 1 to 6 teaspoons (5 mL - 30 mL) |
| Children under 12 years of age | Ask a doctor |
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| GERICARE DOCUSATE SODIUM LIQUID
docusate sodium liquid |
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| Labeler - GERI-CARE PHARMACEUTICALS, CORP (611196254) |
Revised: 7/2021
Document Id: cafb91c4-38df-40cd-b5fa-9afaa395affe
Set id: e50558e1-f0c8-4b03-9109-6a273b61730d
Version: 3
Effective Time: 20210704