LAXATIVE PILLS MAXIMUM STRENGTH- sennosides tablet 
Freds 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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DRUG FACTS

Active ingredient (in each tablet)

Sennosides USP, 25 mg

Purpose

Stimulant laxative

Uses

  •  relief of occasional constipation (irregularity). This product generally produces bowel movement within 6 to 12 hours.

Warnings

Do not use

  • when abdominal pain, nausea, or vomiting are present
  • for longer than 1 week, unless directed by a doctor

Ask a doctor before use if

  •  you notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

  •  you have rectal bleeding
  •  you fail to have a bowel movement after use. These may be signs of a serious condition.

If pregnant or breast-feeding,

 ask a health care 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

  adults and children 12 years of age and older take 2 tablets once or twice daily with a glass of water
  children 6 to under 12 years of age  take 1 tablet once or twice daily with a glass of water
  children under 6 years of ageconsult a doctor

Other information

  • each tablet contains: calcium 40 mg/ tablet
  • each tablet contains: magnesium 10 mg/ tablet
  • each tablet contains: sodium 3 mg/ tablet VERY LOW SODIUM 
  • store at 15º - 30º C (59º-86º F)
  • keep in a dry place
  • do not expose to excessive heat

Inactive ingredients

acacia, anhydrous lactose*, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 Aluminum Lake, iron oxide, iron oxide Black, iron oxide Yellow, isopropyl alcohol*, kaolin, Lake Brilliant Blue FCF*, magnesium stearate, malto dextrin*, microcrystalline cellulose, Opacode Black S-1-17823*, Opagloss 6000P*, polyethylene glycol, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, stearic acid, sugar, talc, tartaric acid*, titanium dioxide.

*contains one or more of these ingredients

Questions or Comments?

Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to active ingredient in maximum strength EX-LAX® †

Maximum Strength

Laxative Pills

Sennosides USP, 25 mg

natural senna ingredient

for gentle, dependable overnight relief

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

† This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Ex-Lax®

Product Label

Freds Inc.

Sennosides, USP 25 mg

LAXATIVE PILLS  MAXIMUM STRENGTH
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-140
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES25 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
TARTARIC ACID (UNII: W4888I119H)  
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL083;S25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-140-032 in 1 CARTON07/08/201012/31/2019
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/08/201012/31/2019
Labeler - Freds Inc (005866116)
Registrant - P & L Development, LLC (800014821)

Revised: 12/2018
Document Id: ce2b2f84-d82d-4927-89e4-eef262371ee1
Set id: 31dc7b5a-f5d6-4f64-80b2-217c74a8b06b
Version: 3
Effective Time: 20181212
 
Freds Inc