DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Docusate (250 mg)

Inactive Ingredients

Polyethylene Glycol 400 Propylene Glycol Gelatin Glycerin Water Sorbitan Sorbitol Fd&c Red No. 40 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance

Imprint: GC425 Shape: oval Color: red Color: yellow Size: 23 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2016-05-18

Medication Information

Warnings and Precautions

All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods.

Indications and Usage

Olds SoftGels Inc

Dosage and Administration

All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods.

Description

ACTIVE INGREDIENT Docusate Sodium 250 mg

Section 50565-1

Keep out of reach of children.

Section 51727-6

INACTIVE INGREDIENTS

Red No. 40

Granular FD and C

Yellow No.6

Granular

Gelatin

Glycerin USP 99 Percent

Polyethylene

Glycol 400 USP PEG 400

Propylene glycol

Purified water

Sorbitol special GC

Section 51945-4

PACKAGE LABEL

Section 55105-1

IMPORTANT

This is a bulk shipment, intended for further processing only. It is not to be used in its present condition and it should be repackaged immediately and labeled strictly in conformance with the Federal Food, Drug and Cosmetic Act and other pertinent government regulations.

Section 55106-9

ACTIVE INGREDIENT

Docusate Sodium 250 mg

Structured Label Content

Indications and Usage (34067-9)

Olds SoftGels Inc

Dosage and Administration (34068-7)

All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods.

Warnings and Precautions (34071-1)

All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS

Red No. 40

Granular FD and C

Yellow No.6

Granular

Gelatin

Glycerin USP 99 Percent

Polyethylene

Glycol 400 USP PEG 400

Propylene glycol

Purified water

Sorbitol special GC

Section 51945-4 (51945-4)

PACKAGE LABEL

Section 55105-1 (55105-1)

IMPORTANT

This is a bulk shipment, intended for further processing only. It is not to be used in its present condition and it should be repackaged immediately and labeled strictly in conformance with the Federal Food, Drug and Cosmetic Act and other pertinent government regulations.

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

Docusate Sodium 250 mg

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Olds SoftGels Inc", "34068-7": "All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods.", "34071-1": "All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods.", "50565-1": "Keep out of reach of children.", "51727-6": "INACTIVE INGREDIENTS Red No. 40 Granular FD and C Yellow No.6 Granular Gelatin Glycerin USP 99 Percent Polyethylene Glycol 400 USP PEG 400 Propylene glycol Purified water Sorbitol special GC", "51945-4": "PACKAGE LABEL", "55105-1": "IMPORTANT This is a bulk shipment, intended for further processing only. It is not to be used in its present condition and it should be repackaged immediately and labeled strictly in conformance with the Federal Food, Drug and Cosmetic Act and other pertinent government regulations. ", "55106-9": "ACTIVE INGREDIENT Docusate Sodium 250 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information