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  5. Label Information: Gentle Laxative

FDA Label for Gentle Laxative

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. OTHER
    15. DISPLAY PANEL

Gentle Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Wal-mart Stores 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.

Otc - Active Ingredient



Active ingredient                 

(In each tablet)

  Bisacodyl 5mg


Purpose



Stimulant Laxative


Indications & Usage



Uses

  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Warnings



Do not use if you cannot swallow without chewing


Otc - Ask Doctor



Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts more than 2 weeks

Otc - When Using



When using this product

  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness and cramps
  • do not use within 1 hour after taking an antacid or milk

Otc - Stop Use



Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a 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 with a glass of water
  • adults and children 12 years and over: take 1 to 3 tablets in a single daily dose
  • children 6 to under 12 years: take 1 tablet in a single daily dose
  • children under 6 years: ask a doctor

Other Information



  • each tablet contains: magnesium 5 mg
  • store at 25°C (77°F) , excursions permitted between 15-30°C (59-86°F)
  • protect from excessive humidity

Inactive Ingredients



acacia, carnauba wax, collodial silicon dioxide, corn starch, FD&C yellow #6, lactose anhydrous, magnesium stearate, methacrylic acid,
microcrystalline cellulose, polyvinyl acetate, shellac, sodium starch glycoale, stearic acid, talc, titanium dioxide, triacetin


Questions Or Comments?



1-888-287-1915


Other



Distributed by:
Walmart Inc.
Bentonville, AR 72716

Product of India

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax® Laxative.


Display Panel



Compare to Dulcolax® Laxative active ingredient*


GENTLE LAXATIVE

BISACODYL 5 mg

  • Overnight Relief
  • Gentle, dependable constipation relief
  • Relief in 6-12 hours


    • 8 TABLETS

    ENTERIC COATED


* Please review the disclaimer below.