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NDC 70518-3319-00 Colace 100 mg/1 Details
Colace 100 mg/1
Colace is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK 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: 70518-3319-00Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners
Product Information
NDC | 70518-3319 |
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Product ID | 70518-3319_d4d8da15-be77-95c7-e053-2a95a90a90a1 |
Associated GPIs | |
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 | Colace |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Docusate sodium |
Product Type | HUMAN OTC DRUG |
Dosage Form | CAPSULE |
Route | ORAL |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/1 |
Substance Name | DOCUSATE SODIUM |
Labeler Name | REMEDYREPACK INC. |
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 70518-3319-00 (70518331900)
NDC Package Code | 70518-3319-0 |
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Billing NDC | 70518331900 |
Package | 30 CAPSULE in 1 BLISTER PACK (70518-3319-0) |
Marketing Start Date | 2021-12-29 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 30d23151-3cd8-4a15-a1da-46aa4be8fb79 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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.
Directions: Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over | take 1-3 capsules daily |
children 2 to under 12 years of age | take 1 capsules daily |
children under 2 years | ask a doctor |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
DRUG: Colace
GENERIC: Docusate sodium
DOSAGE: CAPSULE
ADMINSTRATION: ORAL
NDC: 70518-3319-0
COLOR: red
SHAPE: OVAL
SCORE: No score
SIZE: 12 mm
IMPRINT: RPC;053
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- Docusate sodium 100mg in 1
INACTIVE INGREDIENT(S):
- D&C RED NO. 33
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- SORBITOL
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 6
- TITANIUM DIOXIDE
INGREDIENTS AND APPEARANCE
COLACE
docusate sodium capsule |
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Labeler - REMEDYREPACK INC. (829572556) |