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Gentle Laxative by Healthlife of USA

Dosage form: tablet
Ingredients: BISACODYL 5mg
Labeler: Healthlife of USA
NDC Code: 69517-116

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.

Gentle Laxative
Bisacodyl 5mg

Drug Facts

Gentle Laxative 

Purpose 

Stimulant Laxative

Active Ingerient (in each tablet)

Bisacodyl 5mg

Uses
  • For temporary relief of occasional constipation and irregularity
  • This product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

  • If you cannot swallow without chewing

Ask a doctor before use if you have
  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that last more than 2 weeks

When using this product
  • Do not chew or crush tablet(s)
  • Do not use within 1 hour after taking an antacid or milk 
  • It may cause stomach discomfirt, faintness and cramps

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

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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions
  • Take with a glass of water 
  • Adults and children 12 years of age and over : Take 1 to 3 tablets in a single daily dose
  • Children 6 to under 12 years of age: Take 1 tablet in a single daily dose
  • Children under 6 years of age: Ask a doctor

Other Information
  • Store at controlled room temperature 20°- 25°C  (68°- 77°F)
  • Read all product information before using 
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 

Inactive ingredients
  • Colloidal silicon dioxide
  • Croscarmellose sodium
  • Dicalcium phosphate 
  • FD&C Blue#1
  • FD&C Blue#2
  • Magnesium Stearate
  • Microcrystalline cellulose
  • Polyethylene glycol
  • Polyvinyl alcohol
  • Talc
  • Titanium dioxide

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

Gentle Laxative
Bisacodyl 5 mgCompare to Dulcolax® Laxative active ingredients

Distributed by:
Healthlife of USA LLCRahwayNJ 07065www.healthlifeofusa.com

GENTLE LAXATIVE 
gentle laxative tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-116
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (DEACETYLBISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
TALC 
TITANIUM DIOXIDE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69517-116-241 BOTTLE in 1 CARTON
124 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/31/2017
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIOperations
Healthlife of USA079656178repack(69517-116)
Establishment
NameAddressID/FEIOperations
Time Cap Laboratiries, Inc.037052099manufacture(69517-116), pack(69517-116)

Revised: 06/2017
 
Healthlife of USA

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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