- Clinical Pharmacology
- Indications & Usage
- Side Effects
- Dosage & Administration
- How Supplied
- Patient Counseling Information
- Supplemental Patient Material
- Boxed Warning
- Patient Package Insert
FULL PRESCRIBING INFORMATION: CONTENTS*
- Drug Facts
- Active ingredient(in each capsule)
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
FULL PRESCRIBING INFORMATION
Active ingredient(in each capsule)
Docusate sodium 50 mg
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Do not use
- if you are presently taking mineral oil, unless told to do so by a doctor
Ask a doctor before use if you have
- stomach pain
- noticed a sudden change in bowel habits that lasts over 2 weeks
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
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.
- 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|
D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, PEG 400, propylene glycol, sorbitol
(8am-5pm, EST, Mon.-Fri.).
PRINCIPAL DISPLAY PANEL
Docusate Sodium capsules USP 50mg
Each Softgel Contains:
(Docusate Sodium USP 50mg)
LOT NO :
DRUM NO :
MFG DATE :
NDC NO : 68210-0402-
EXP DATE :
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.
SOFTGEL HEALTHCARE PVT LIMITED
LABELLER CODE : 35916
LIC NO. : TN/DRUGS/00002124
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
DOCUSATE SODIUM CAPSULE, LIQUID FILLED