LAXATIVE PILLS MAXIMUM STRENGTH- sennosides tablet

Laxative pills by

Drug Labeling and Warnings

Laxative pills by is a Otc medication manufactured, distributed, or labeled by Care One (American Sales Company), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 age: consult 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
• *This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Ex-Lax®

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

sennosides 25 mg

INGREDIENTS AND APPEARANCE

LAXATIVE PILLS  MAXIMUM STRENGTH
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-142
Route of Administration	ORAL

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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
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	08/05/2010	01/01/2022
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	08/05/2010	01/01/2022

Labeler - Care One (American Sales Company) (809183973)

Registrant - P & L Development, LLC (800014821)