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NDC 54838-0116-80 Silace 10 mg/mL Details
Silace 10 mg/mL
Silace is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Lannett Company, Inc.. 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: 54838-0116-80Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners
Product Information
NDC | 54838-0116 |
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Product ID | 54838-116_bb16b285-0ad1-41e8-b59b-3de9ca3936fc |
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 | Brand |
Proprietary Name | Silace |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Docusate sodium |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | ORAL |
Active Ingredient Strength | 10 |
Active Ingredient Units | mg/mL |
Substance Name | DOCUSATE SODIUM |
Labeler Name | Lannett Company, Inc. |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part334 |
Listing Certified Through | n/a |
Package
Package Images

NDC 54838-0116-80 (54838011680)
NDC Package Code | 54838-116-80 |
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Billing NDC | 54838011680 |
Package | 473 mL in 1 BOTTLE, PLASTIC (54838-116-80) |
Marketing Start Date | 1990-10-05 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.02123 |
Pricing Unit | ML |
Effective Date | 2024-01-17 |
NDC Description | SILACE 50 MG/5 ML LIQUID |
Pharmacy Type Indicator | C/I |
OTC | Y |
Explanation Code | 4, 5 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 38733915-c3a8-4e44-8453-5d4bd592f3f8 Details
Uses
Warning
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
- take as indicated by doctor
- this product must be given in a 6 to 8 oz. glass of milk or fruit juice or infant's formula to prevent throat irritation. Dose may be taken as a single daily dose or in divided doses
- dosage should be adjusted to individual response
- higher doses are recommended for initial therapy
- the effect on stools is usually apparent 1 to 3 days after the first dose
Adults and children over 12 years | 50 to 200 mg (1 to 4 teaspoonful) |
Children 6 to under 12 years | 50 to 100 mg (1 to 2 teaspoonful) |
Children 3 to under 6 years | 25 to 50 mg(1/2 to 1 teaspoonful) |
Children under 3 years of age | Ask a doctor |
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
SILACE
docusate sodium liquid |
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Labeler - Lannett Company, Inc. (002277481) |
Revised: 8/2018
Document Id: bb16b285-0ad1-41e8-b59b-3de9ca3936fc
Set id: 38733915-c3a8-4e44-8453-5d4bd592f3f8
Version: 16
Effective Time: 20180813