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  5. Label Information: Onelax

FDA Label for Onelax

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (PER SUPPOSITORY)
    2. PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DO NOT USE LAXATIVE PRODUCTS
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENT
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Onelax Product Label

The following document was submitted to the FDA by the labeler of this product Akron Pharma 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 Ingredients (Per Suppository)



Bisacodyl USP, 10  mg


Purpose



Laxative


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Uses



  • for relief of occasional constipation
  • this product usually produces bowel movement in 1/4 to 1 hour

Warnings



For rectal use only.


Do Not Use Laxative Products



  • when abdominal pain, nausea or vomiting are present
  • for a period longer than one week

Ask A Doctor Before Use If You Have



noticed a sudden change in bowel habits that persist over a period of 2 weeks


When Using This Product



it may cause abdominal discomfort, faintness, rectal burning and mild cramps


Stop Use And Ask A Doctor If



rectal bleeding occurs, or you fail to have a bowel movement after using a laxative. This may indicate a serious condition.


If Pregnant Or Breast-Feeding



ask a health professional before use.


Directions



  • adults and children 12 years of age and older
  • detach one suppository from the strip
  • remove from wrapper before inserting into the rectum
  • the rectal suppository dose is one suppository per day or as directed by a doctor
  • children under 12 years of age consult a doctor

Other Information



store below 30° C (86° F)


Inactive Ingredient



hydrogenated vegetable oil

Manufactured for:
Akron Pharma Inc.,
Fairfield, NJ-07004
www.akronpharma.com


Package Label.Principal Display Panel



12PK - 12pk

12PK - 12pk


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