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  5. Label Information: Womens Gentle Laxative

FDA Label for Womens Gentle Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. OTC - DO NOT USE
    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. PRINCIPAL DISPLAY PANEL

Womens Gentle Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Dolgencorp, 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.

Active Ingredient (In Each Softgel)



Bisacodyl (USP) 5 mg


Purpose



Stimulant laxative


Uses



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

Otc - Do Not Use



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
  • 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 over1 to 3 tablets in a single daily dose
    children 6 to under 12 years of age1 tablet in a single daily dose
    children under 6 years of ageask a doctor


Other Information



  • store at 20-25°C (68-77°F)
  • protect from excessive humidity

Inactive Ingredients



dextrose monohydrate, D&C Red #27, FD&C Blue #1, hypromellose, lactose monohydrate, lecithin, magnesium stearate, maltodextrin, methacrylic acid copolymer, methyl cellulose, pregelatinized starch, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate


Questions Or Comments?



1-888-333-9792


Principal Display Panel



Compare to the active ingredient in Dulcolax® Pink® Laxative Tablets*

Women's Gentle Laxative
Bisacodyl USP 5 mg

• stimulant laxative
• gentle, overnight relief

25 tablets


* Please review the disclaimer below.