C-Lax Laxative: Package Insert and Label Information

C-LAX LAXATIVE- bisacodyl tablet, sugar coated
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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.

Active ingredient (in each enteric coated tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses

  • for gentle, overnight relief of occasional constipation (irregularity)

  • this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

  • in children under 6 years of age

  • in persons who cannot swallow without chewing

Ask a doctor before use if you have

  • abdominal pain

  • nausea

  • vomiting

  • sudden change in bowel movements that persist over a period of 2 weeks

When using this product

  • do not use for a period longer than 1 week unless directed by a doctor

  • you may experience abdominal discomfort, faintness and cramps

Stop use and ask a doctor if

  • rectal bleeding occurs

  • you fail to have a bowel movement

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 (1-800-222-1222) right away.

Directions

  • do not chew or crush tablets

  • do not take within 1 hour after taking an antacid or milk

adults and children over 12 years of age oral dosage is 1 to 3 tablets in a single or divided daily dose
children 6 to under 12 years of age oral dosage is 1 tablet in a single daily dose
children under 6 years of age ask a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

  • protect from moisture

  • use by expiration date on package

Inactive ingredients

acacia, ammonium hydroxide, black iron oxide, calcium carbonate, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, methylparahydroxy benzoate, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparahydroxy benzoate, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS pharmacy™

*Compare to the active ingredient in Correctol®*

C-LAX
LAXATIVE
BISACODYL STIMULANT LAXATIVE

Bisacodyl 5 mg

For gentle, dependable
overnight relief

250 TABLETS Actual Size

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

*This product is not manufactured or distributed by MSD Consumer Care, Inc., owner of the registered trademark Correctol®.

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2014 CVS/pharmacy
CVS.com®
1-800-SHOP CVS
50844 REV0412B32652

V-14236

CVS 44-326
(click image for full-size original)

CVS 44-326

C-LAX LAXATIVE
bisacodyl tablet, sugar coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-632
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISACODYL (BISACODYL) BISACODYL 5 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA
FERROSOFERRIC OXIDE
CALCIUM CARBONATE
CARNAUBA WAX
D&C RED NO. 27
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
Polyvinyl Acetate Phthalate
POVIDONES
PROPYLENE GLYCOL
SODIUM ALGINATE
SODIUM BENZOATE
SODIUM BICARBONATE
STEARIC ACID
SUCROSE
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 44;326
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-632-11 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 60 TABLET, SUGAR COATED in 1 BLISTER PACK This package is contained within the CARTON (59779-632-11)
2 NDC:59779-632-52 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 90 TABLET, SUGAR COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (59779-632-52)
3 NDC:59779-632-13 250 TABLET, SUGAR COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 02/12/2005 12/14/2018
Labeler — WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK (59779-632)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 MANUFACTURE (59779-632)

Revised: 01/2016 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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