FDA Label for Docuzen
View Indications, Usage & Precautions
Docuzen Product Label
The following document was submitted to the FDA by the labeler of this product Village Pharma. 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 Ingredients (In Each Tablet)
Sennosides from Senna Concentrate 8.6mg
Docusate Sodium 50mg
Purpose
Laxative
Stool Softner
Uses
• relieves occasional constipation (irregularity)• generally produces a bowel movement in 6-12 hours
Warnings
Do not use
• laxative products for longer than 1 week unless directed by a doctor• if you are taking mineral oils, unlesss directed by a doctor
Ask A Doctor Before Use If You Have
• stomach pain• nausea• vomiting• noticed a sudden change in bowel habits that continues over a period of 2 weeks
Stop Use And Ask A Doctor If
• you have rectal bleeding• you fail to have a bowel movement after the use of a laxative.
These may indicate a serious condition.
If Pregnant Or Breast Feeding,
ask a healthcare professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center immediately.
Directions
• take preferably at bedtime or as directed by a doctor
age | starting dosage | maximum dosage |
Adults and children 12 years and over | 2 tablets once a day | 4 tablets twice a day |
Children 6 to under 12 years | 1 tablet once a day | 2 tablets twice a day |
Children 2 to under 6 years | 1/2 tablet once a day | 1 tablet twice a day |
Children under 2 years | ask a doctor | ask a doctor |
Other Information
• each tablet contains 10 mg of calcium, sodium 5 mg• store at 25°C (77°F); excursions permitted between 15o-30oC (59o-86oF)
Inactive Ingredients
croscarmellose Sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc & titanium dioxide.
Questions Or Comments?
1-800-828-0464 Mon-Fri 8 AM to 4 PM
Package Label.Principal Display Panel
VillagePharma
NDC 71574-700-60
DOCUZEN
Sennosides 8.6mg &
Docusate Sodium 50mg
60 TABLETS
Manufactured in the USA
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