Label: KONSYL OVERNIGHT RELIEF SENNA PROMPT- plantago seed, sennosides capsule

  • NDC Code(s): 0224-1860-60, 0224-1860-81, 0224-1860-90
  • Packager: Konsyl Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 10, 2018

If you are a consumer or patient please visit this version.

  • Konsyl Overnight Relief Senna Prompt Capsules
  • Active Ingredients (in each capsule)

    • Psyllium 500 mg
    • Sennosides 9 mg
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  • Purpose

    • Bulk-forming laxative
    • Stimulant laxative
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  • Uses

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

    Allergy Alert: This product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium. 

    Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

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  • Ask a doctor before use if you have

    • abdominal pain, nausea, or vomiting
    • a sudden change in bowel habits that persists over 2 weeks
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  • Stop use and ask a doctor if

    • you fail to have a bowel movement or have rectal bleeding. These  could be signs of a serious condition.
    • you need to use a laxative for more than 1 week
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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • Take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without  enough liquid may cause choking.
      See choking warning.
    • follow dosage below or use as directed by a doctor
    adults and children 12 years and over
    2-4 capsules, 1-2 times per day
    children under 12 years
    consult a doctor
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  • Inactive Ingredients:

    D and  C yellow #10 Al. lake, FD and C blue #1 Al.  lake,  FD and C yellow #6, gelatin, polyethylene glycol, polysorbate 80.

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  • Other information

    • keep tightly closed
    • store at room temperature
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  • Questions?

    1-800-356-6795 8:30am to 5pm ET

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  • Manufactured By:

    Konsyl Pharmaceuticals, Inc.

    Easton, MD 21601

    1-800-356-6795

    www.konsyl.com

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  • Package Labeling
  • INGREDIENTS AND APPEARANCE
    KONSYL OVERNIGHT RELIEF SENNA PROMPT 
    plantago seed, sennosides capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0224-1860
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PLANTAGO SEED (UNII: 9C60Y73166) (PLANTAGO SEED - UNII:9C60Y73166) PLANTAGO SEED 500 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 9 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    Color white (CLEAR) Score no score
    Shape CAPSULE Size 21mm
    Flavor Imprint Code SennaPrompt
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0224-1860-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2011 07/01/2019
    2 NDC:0224-1860-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2011 07/01/2018
    3 NDC:0224-1860-81 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 04/01/2011
    Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
    Registrant - Konsyl Pharmaceuticals, Inc. (102463866)
    Establishment
    Name Address ID/FEI Business Operations
    Konsyl Pharmaceuticals, Inc. 102463866 manufacture(0224-1860)
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