SENNA LAXATIVE- sennosides tablet 
Care One (American Sales Company)

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 8.6 mg

Purpose

Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement within 6- 12 hours.

Warnings

Do not use

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

Ask a doctor before using 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

  • take preferably at bedtime or as directed by a doctor 
age starting dosagemaximum dosage 
 adults and children 12 years of age and over 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

  • each tablet contains: calcium 25 mg
  • store at 25o C (77o F); excursions permitted between 15_30oC (59o_86oF)

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, liquid paraffin*, magnesium stearate, maltodextrin*, microcrystalline cellulose, mineral oil*, polyethylene glycol*, polyvinyl alcohol*, silicon dioxide*, sodium lauryl sulfate*, stearic acid*, talc*

*contains one or more of these ingredients

Questions or comments?

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

Principal Display Panel

Compare to the active ingredient in Senokot®†

Senna Laxative 

(Standardized Senna Concentrate) Laxative Sennosides, 8.6 mg

TABLETS

†This product is not manufactured or distributed by Purdue Products L.P., distributor of Senokot®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

Product Label

Sennosides 8.6 mg

CAREONE Senna Laxative

SENNA LAXATIVE 
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-486
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 0813;AV;TCL080;S8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-486-011 in 1 BOX12/31/201512/31/2020
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33412/31/201512/31/2020
Labeler - Care One (American Sales Company) (809183973)

Revised: 10/2019
 
Care One (American Sales Company)