LAXATIVE PILLS MAXIMUM STRENGTH- 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.

----------

DRUG FACTS

Active ingredient (in each tablet)

Sennosides USP, 25 mg

Purpose

Stimulant laxative

Uses

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 age consult a doctor

Other information

Inactive ingredients

acacia, 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, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, stearic acid, sugar, talc, and titanium dioxide. May also contain:  anhydrous lactose, isopropyl alcohol, Lake Brilliant Blue FCF, malto dextrin, Opacode Black S-1-17823, Opagloss 6000P, tartaric acid

Principal Display Panel

Compare to the active ingredient in maximum strength EX-LAX® *

Laxative Pills

Maximum Strength

for gentle, dependable overnight relief

25 mg Sennosides**

**Natural senna ingredient

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

Distributed by: American Sales Company

4201 walden avenue, Lancaster, NY 14086

www.care1.com

Product Label

CareOne

sennosides 25 mg

LAXATIVE PILLS  MAXIMUM STRENGTH
sennosides tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-142
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 25 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA (UNII: 5C5403N26O)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
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 GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (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
Color BLUE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code TCL083;S25
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-142-24 2 in 1 CARTON
1 12 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 08/05/2010
Labeler - Care One (American Sales Company) (809183973)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: c1c6ffd2-d811-4874-9143-4970ac17f595
Set id: d261e246-bd48-4da1-b760-a00a89788845
Version: 1
Effective Time: 20121228
 
Care One (American Sales Company)