Care One Gentle Laxative

Care One Gentle Laxative
SPL v5
SPL
SPL Set ID 4bb375a0-8ec3-4769-9802-832b8a280e7d
Route
ORAL
Published
Effective Date 2021-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Calcium Sulfate Anhydrous Anhydrous Lactose Carnauba Wax Silicon Dioxide Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Gelatin Ferrosoferric Oxide Acacia Ferric Oxide Yellow Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Polyvinyl Acetate Phthalate Povidone Shellac Sodium Starch Glycolate Type A Corn Stearic Acid Sucrose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL003 Shape: round Color: orange Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-30

Description

Active ingredient                  (In each tablet)   Bisacodyl 5mg

Purpose

Stimulant Laxative


Medication Information

Indications and Usage

Uses

  • relieves occasional constipation and irregularity
  • this product generally produces a bowel movement in 6 to 12 hours

Purpose

Stimulant Laxative

Dosage and Administration
  • take with a glass of water
  • adults and children 12 years and over: take 1 to 3 tablets in a single daily dose
  • children 6 to under 12 years: take 1 tablet in a single daily dose
  • children under 6 years: ask a doctor
Description

Active ingredient                  (In each tablet)   Bisacodyl 5mg

Section 55106-9

Active ingredient                 

(In each tablet)

  Bisacodyl 5mg

Warnings

Do not use if you cannot swallow without chewing

Ask a doctor before use if you have

■ stomach pain, nausea or vomiting

■ a sudden change in bowel habits that lasts more than 2 weeks

When using this product

■ do not chew or crush tablet(s)

■ it may cause stomach discomfort, faintness and

cramps

■ do not use within 1 hour after taking an antacid

or milk

Display Panel

GENTLE LAXATIVE

BISACODYL 5 mg



GENTLE YET EFFECTIVE STIMULANT LAXATIVE



25 TABLETS



ENTERIC COATED

Inactive Ingredients

Acadia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Yellow #10 Aluminum Lake, FD&C yellow #6 aluminum lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

Questions Or Comments?

1-888-333-9792

Stop Use and Ask A Doctor If



■ you have rectal bleeding or no bowel movement

after using this product. These could be signs of

a serious condition.

■ you need to use a laxative for more than 1 week

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 1(800) 222-1222.


Structured Label Content

Indications and Usage (34067-9)

Uses

  • relieves occasional constipation and irregularity
  • this product generally produces a bowel movement in 6 to 12 hours

Dosage and Administration (34068-7)
  • take with a glass of water
  • adults and children 12 years and over: take 1 to 3 tablets in a single daily dose
  • children 6 to under 12 years: take 1 tablet in a single daily dose
  • children under 6 years: ask a doctor
Section 55106-9 (55106-9)

Active ingredient                 

(In each tablet)

  Bisacodyl 5mg

Purpose

Stimulant Laxative

Warnings

Do not use if you cannot swallow without chewing

Ask a doctor before use if you have

■ stomach pain, nausea or vomiting

■ a sudden change in bowel habits that lasts more than 2 weeks

When using this product

■ do not chew or crush tablet(s)

■ it may cause stomach discomfort, faintness and

cramps

■ do not use within 1 hour after taking an antacid

or milk

Display Panel (DISPLAY PANEL)

GENTLE LAXATIVE

BISACODYL 5 mg



GENTLE YET EFFECTIVE STIMULANT LAXATIVE



25 TABLETS



ENTERIC COATED

Inactive Ingredients (Inactive ingredients)

Acadia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Yellow #10 Aluminum Lake, FD&C yellow #6 aluminum lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)



■ you have rectal bleeding or no bowel movement

after using this product. These could be signs of

a serious condition.

■ you need to use a laxative for more than 1 week

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

 ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

 In case of overdose, get medical help or contact a Poison Control Center right away 1(800) 222-1222.


Advanced Ingredient Data


Raw Label Data

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