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  5. Label Information: Stool Softener Plus Stimulant Laxative

FDA Label for Stool Softener Plus Stimulant Laxative

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. IF PREGNANT OR BREAST-FEEDING,
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Stool Softener Plus Stimulant Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution Inc.. 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.

Drug Facts




Active Ingredients (In Each Tablet)



Docusate sodium 50 mg
Sennosides 8.6 mg


Purpose



Stool softener

Stimulant Laxative


Uses



■ relieves occasional constipation (irregularity)
■ generally produces bowel movement in 6-12 hours


Warnings



Warnings


Do Not Use



■ laxative products for longer than 1 week unless directed by
a doctor
■ if you are presently taking mineral oil, unless directed by a
doctor


Ask A Doctor Before Use If You Have



■ stomach pain ■ nausea ■ vomiting
■ 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.


Otc - Pregnancy Or Breast Feeding



Drug Facts (continued)


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, preferably in the evening, or in divided doses

 adults and children 12 years
and over 		 take 2-4 tablets daily
 children 6 to under 12 years
of age 		 take 1-2 tablets daily
 children 2 to under 6 years
of age 		 take up to 1 tablet daily
 children under 2 ask a doctor


Other Information



■ each tablet contains: calcium 20 mg, sodium 6 mg
■ store at 25°C (77°F); excursions permitted between
15°-30°C (59°-86°F)


Inactive Ingredients



Colloidal silicon dioxide, croscarmellose sodium, dicalcium
phosphate, FD&C Red #40, hypermellose, magnesium
stearate, maltodextrin, microcrystalline cellulose, polyethylene
glycol-400, purified water, sodium benzoate, stearic acid,
titanium dioxide


Questions Or Comments?



1-888-333-9792


Principal Display Panel



COMPARE TO THE ACTIVE
INGREDIENTS OF PERI-COLACE®†

Stool Softener

with Stimulant Laxative

Docusate Sodium 50 mg
Sennosides 8.6 mg

Relieves
Constipation

ACTUAL SIZE

100 TABLETS


* Please review the disclaimer below.