FDA Label for Sennosides And Docusate Sodium

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH TABLET)
PURPOSE
USES
WARNINGS
ASK A DOCTOR BEFORE USE IF YOU
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
PACKAGING INFORMATION
PACKAGE/LABEL DISPLAY PANEL – CARTON – 8.6 MG/50 MG
PACKAGE/LABEL DISPLAY PANEL – BLISTER – 8.6 MG/50 MG

Sennosides And Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product American Health Packaging. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener
Laxative

Uses

relieves occasional constipation (irregularity)
this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use for more than one week unless directed by a doctor.

Ask A Doctor Before Use If You

have abdominal pain, nausea or vomiting
are taking mineral oil
have noticed a sudden change in bowel habits that lasts over two 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 may indicate a serious condition.

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

do not exceed 8 tablets in 24 hours
Adults and children 12 years of age and older take 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor; the maximum dose should be 4 tablets in the morning and 4 tablets at bedtime
Children under 12 years ask a doctor

Other Information

each tablet contains: calcium 20 mg, sodium 3 mg
store at controlled room temperature
Keep this and all drugs out of reach of children.
FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

Packaging Information

The drug product contained in this package is from NDC # 57896-555, Geri-Care Pharmaceuticals Corp.

Distributed by:
American Health Packaging, Columbus, Ohio 43217

762201
0462201/0621

Package/Label Display Panel – Carton – 8.6 Mg/50 Mg

8.6 mg/50 mg Sennosides and Docusate Sodium Tablets Carton - Carton

NDC 60687- 622-01

Sennosides* and Docusate Sodium Tablets
Natural Vegetable Laxative with Stool Softener
*Standardized Senna Concentrate

8.6 mg/50 mg

100 Tablets (10 x 10)

Drug Facts
Active ingredients (in each tablet)......................................................................Purpose
Docusate Sodium 50 mg...............................................................................Stool softener
Sennosides 8.6 mg............................................................................................... Laxative

The drug product contained in this package is from
NDC # 57896-555, Geri-Care Pharmaceuticals Corp.