Konsyl Overnight Relief Senna Prompt Capsules

Konsyl Overnight Relief Senna Prompt by

Drug Labeling and Warnings

Konsyl Overnight Relief Senna Prompt by is a Otc medication manufactured, distributed, or labeled by Konsyl Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KONSYL OVERNIGHT RELIEF SENNA PROMPT- plantago seed, sennosides capsule 
Konsyl Pharmaceuticals, Inc.

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.

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Konsyl Overnight Relief Senna Prompt Capsules

Konsyl Overnight Relief Senna Prompt Capsules

Active Ingredients (in each capsule)

  • Psyllium 500 mg
  • Sennosides 9 mg

Purpose

  • Bulk-forming laxative
  • Stimulant laxative

Uses

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

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.

Ask a doctor before use if you have

  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits that persists over 2 weeks

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

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

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.

Other information

  • keep tightly closed
  • store at room temperature

Questions?

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

Manufactured By:

Konsyl Pharmaceuticals, Inc.

Easton, MD 21601

1-800-356-6795

www.konsyl.com

Package Labeling

Label
KONSYL OVERNIGHT RELIEF SENNA PROMPT 
plantago seed, sennosides capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0224-1860
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PLANTAGO SEED (UNII: 9C60Y73166) (PLANTAGO SEED - UNII:9C60Y73166) PLANTAGO SEED500 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES9 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
Colorwhite (CLEAR) Scoreno score
ShapeCAPSULESize21mm
FlavorImprint Code SennaPrompt
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0224-1860-9090 in 1 BOTTLE; Type 0: Not a Combination Product04/01/201107/01/2018
2NDC: 0224-1860-6060 in 1 BOTTLE; Type 0: Not a Combination Product04/01/201107/01/2018
3NDC: 0224-1860-8160 in 1 BOTTLE; Type 0: Not a Combination Product04/01/201107/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/01/201107/01/2018
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
Establishment
NameAddressID/FEIBusiness Operations
Konsyl Pharmaceuticals, Inc.102463866manufacture(0224-1860)

Revised: 12/2019
 
Konsyl Pharmaceuticals, Inc.