Laxative description, usages, side effects, indications, overdosage, supplying and lots more!

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Laxative

QUALITY CHOICE (Chain Drug Marketing Association)

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Sennosides USP, 25 mg

Purpose

Stimulant laxative

Laxative Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you

  • are taking a prescription drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

When using this product

  • do not use for a period longer than 1 week

Stop use and ask a doctor if

  • rectal bleeding or failure to have a bowel movement occur after use of a laxative

These may be signs of 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

  • swallow tablet(s) with a glass of water
  • swallow tablet(s) whole, do not crush, break, or chew
  adults and children 12 years of age and older   take 2 tablets once or twice daily
  children 6 to under 12 years of age   take 1 tablet once or twice daily
  children under 6 years of age   ask a doctor

Laxative Other information

  • each tablet contains: calcium 40 mg
  • each tablet contains: magnesium 10 mg
  • each tablet contains: sodium 3 mg
  • very low sodium
  • store between 20-25ºC (68-77ºF)

Inactive ingredients

acacia, ammonium hydroxide*, anhydrous lactose*, calcium phosphate dihydrate*, calcium sulfate anhydrous*, carnauba wax, corn starch*, croscarmellose sodium, dicalcium phosphate*, FD&C blue #1 aluminum lake, hypromellose*, iron oxide*, iron oxide black, iron oxide yellow*, isopropyl alcohol*, kaolin*, magnesium stearate, microcrystalline cellulose, n-butyl alcohol*, polyethylene glycol, povidone*, propylene glycol*, shellac, silicon dioxide*, sodium lauryl sulfate*, stearic acid*, sucrose, talc, tartaric acid*, titanium dioxide, white wax*

*contains one or more of these ingredients

Questions or comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in ex-lax® MAXIMUM STRENGTH

Maximum Strength

Laxative

Stimulant Laxative

Sennosides USP, 25 mg

Gentle, dependable

Overnight Relief

Tablets

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

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile, Novi, MI  48376-0995

www.qualitychoice.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Laxative
Quality Choice Maximum Strength Laxative Tablet

Laxative

Sennosides TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63868-549
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SENNOSIDES SENNOSIDES 25 mg

Inactive Ingredients

Ingredient Name Strength
ACACIA
AMMONIA
ANHYDROUS LACTOSE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
CALCIUM SULFATE ANHYDROUS
carnauba wax
STARCH, CORN
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C BLUE NO. 1
ALUMINUM OXIDE
HYPROMELLOSES
ferric oxide red
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
ISOPROPYL ALCOHOL
KAOLIN
MAGNESIUM STEARATE
cellulose, microcrystalline
BUTYL ALCOHOL
POLYETHYLENE GLYCOLS
POVIDONES
propylene glycol
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STEARIC ACID
SUCROSE
talc
tartaric acid
titanium dioxide
white wax

Product Characteristics

Color Size Imprint Code Shape
BLUE 11 mm TCL083;S25 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:63868-549-24 24 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-03-31


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