SENNA- sennosides tablet 
Advance Pharmaceutical 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.

----------

Senna 8.6mg tabs

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

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

 a ge
 starting dosage
 maximum dosage
 adults and children 12 years of age or older
 2 tablets once a day
 4 tablets twice a day
 children 6 to under 12 years
 1 tablet once a day
 2 tablets twice a day
 children 2 to under 6 years
 1/2 tablet once a day
 1 tablet twice a day
 children under 2 years
 ask a doctor
 ask a doctor

Other information

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, , magnesium stearate, microcrystalline cellulose, mineral oil

Questions or comments?

call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Principal Display Panel

NDC: 17714-122-01

Senna 8.6mg

senna 8.6mg

SENNA 
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-122
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL080
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17714-122-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/01/2017
Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Time Cap Laboratories, Inc.037052099manufacture(17714-122)

Revised: 10/2017
Document Id: 5cc98885-35c9-38b3-e053-2991aa0a8f76
Set id: 18d7bd07-f3a3-4140-bfb6-4e734f9b6649
Version: 2
Effective Time: 20171030
 
Advance Pharmaceutical Inc.