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  5. Label Information: Clear Stool Softener

FDA Label for Clear Stool Softener

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT(IN EACH SOFTGEL)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - ASK DOCTOR/PHARMACIST
    7. OTC - DO NOT USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. OTC - QUESTIONS
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clear Stool Softener Product Label

The following document was submitted to the FDA by the labeler of this product Family Dollar (family Wellness). 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.

Other



Drug Facts

Distributed by:
MIDWOOD BRANDS, LLC
500 Volvo Pkwy
Chesapeake, VA 23320 USA


Active Ingredient(In Each Softgel)



Docusate sodium 50 mg


Purpose



Stool softener


Uses



■ relieves occasional constipation (irregularity)
■ generally produces bowel movement in 12 to 72 hours


Warnings



Do not use
■ if you are presently taking mineral oil, unless told to do
so by a doctor


Otc - Ask Doctor/Pharmacist



Ask a doctor before use if you have
■ stomach pain ■ nausea ■ vomiting
■ noticed a sudden change in bowel habits that lasts over
2 weeks


Otc - Do Not Use



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 stool softener laxative for more than
1 week


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional
before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right
away. 1-800-222-1222


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 to 6 softgels
daily
children 2 to under 12 years
of age 		take 1 to 3 softgels
daily
children under 2 yearsask a doctor


Other Information



■ each softgel contains: sodium 0.02 mg 

■ store at 25°C (77°F); excursions permitted between
15°-30°C (59°-86°F). 


Inactive Ingredients



gelatin, glycerin, polyethylene glycol-400, povidone
(PVP K-30), propylene glycol, purified water, sorbitol
solution


Otc - Questions



Questions or comments? 1-888-333-9792


Package Label.Principal Display Panel



Compare to the

active ingredient
in Colace® Clear*

Clear Stool Softener
DOCUSATE SODIUM, 50 mg


* Please review the disclaimer below.