Docusate Sodium Capsules Usp 50 Mg
0ecd8576-5bc4-45ca-86d8-e6b73ef5aace
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Docusate sodium 50 mg
Purpose
Stool softener
Medication Information
Purpose
Stool softener
Description
Docusate sodium 50 mg
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Section 42229-5
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
Stop use and ask a doctor if
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
Section 50569-3
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
Section 50570-1
Do not use
- if you are presently taking mineral oil, unless told to do so by a doctor
Section 53413-1
Questions? 1-888-726-7535
(8am-5pm, EST, Mon.-Fri.).
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
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 1-6 capsules daily |
| children 2 to under 12 years of age | take 1-3 capsules daily |
| children under 2 years | ask a doctor |
Active Ingredient
Docusate sodium 50 mg
Inactive Ingredients
D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, PEG 400, propylene glycol, sorbitol
Principal Display Panel
Docusate Sodium capsules USP 50mg
Each Softgel Contains:
(Docusate Sodium USP 50mg)
LOT NO :
DRUM NO :
MFG DATE :
QUANTITY :
NDC NO : 68210-0402-
EXP DATE :
WARNING:
KEEP OUT OF REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C. ACT AND REGULATIONS THEREUNDER.
MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE : 35916
LIC NO. : TN/DRUGS/00002124
MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039
CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
- 1 – 10
- 2 – 30
- 3 – 100
- 4 – 1000
- 5 – 16000
Structured Label Content
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Section 42229-5 (42229-5)
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
Section 50569-3 (50569-3)
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
Section 50570-1 (50570-1)
Do not use
- if you are presently taking mineral oil, unless told to do so by a doctor
Section 53413-1 (53413-1)
Questions? 1-888-726-7535
(8am-5pm, EST, Mon.-Fri.).
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Purpose
Stool softener
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 1-6 capsules daily |
| children 2 to under 12 years of age | take 1-3 capsules daily |
| children under 2 years | ask a doctor |
Active Ingredient (Active ingredient)
Docusate sodium 50 mg
Inactive Ingredients (Inactive ingredients)
D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, PEG 400, propylene glycol, sorbitol
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Docusate Sodium capsules USP 50mg
Each Softgel Contains:
(Docusate Sodium USP 50mg)
LOT NO :
DRUM NO :
MFG DATE :
QUANTITY :
NDC NO : 68210-0402-
EXP DATE :
WARNING:
KEEP OUT OF REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C. ACT AND REGULATIONS THEREUNDER.
MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE : 35916
LIC NO. : TN/DRUGS/00002124
MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039
CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
- 1 – 10
- 2 – 30
- 3 – 100
- 4 – 1000
- 5 – 16000
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:54:58.306666 · Updated: 2026-03-14T22:52:13.708968