989 Senna S Sennosides 8.6mg And Docusate Sodium 50mg

989 Senna S Sennosides 8.6mg And Docusate Sodium 50mg
SPL v8
SPL
SPL Set ID 6cd22881-db60-9045-e053-2991aa0ae08a
Route
ORAL
Published
Effective Date 2022-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Titanium Dioxide Carnauba Wax Silicon Dioxide Calcium Phosphate, Dibasic, Dihydrate Food Yellow 3 Free Acid Croscarmellose D&c Yellow No. 10 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Sodium Benzoate Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: TCL;081 Shape: round Color: orange Size: 10 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-22

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener laxative Stimulant laxative


Medication Information

Purpose

Stool softener laxative

Stimulant laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6 -12 hours
Directions
  • take preferably at bedtime or as directed by a doctor
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable

age

starting

dosage

maximum

dosage

adults and children 12

years of age and over

2 tablets

once a day

4 tablets

twice a day

children 6 to

under 12 years

1 tablet

once a day

2 tablets

twice a day

children 2 to

under 6 years

1/2 tablet

once a day

1 tablet

twice a day

children under 2 years

ask a doctor

ask a doctor

Do Not Use
  • this product if you are presently taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
Package Label

Other Information
  • each tablet contains: calcium 20 mg, sodium 6 mg (VERY LOW SODIUM)
  • store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow#10 aluminum lake, FD&C yellow#6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Questions Or Comments?

Call toll free 1-800-MEDLINE (633-5463)

Monday-Friday 9AM-5PM CST

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and foreign materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: OTCM00011

V1 RE22HND

Stop Use and Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could 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.

Active Ingredient (in Each Tablet)
  • Docusate sodium 50 mg
  • Sennosides 8.6 mg
Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel movements that persists over 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6 -12 hours
Purpose

Stool softener laxative

Stimulant laxative

Directions
  • take preferably at bedtime or as directed by a doctor
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable

age

starting

dosage

maximum

dosage

adults and children 12

years of age and over

2 tablets

once a day

4 tablets

twice a day

children 6 to

under 12 years

1 tablet

once a day

2 tablets

twice a day

children 2 to

under 6 years

1/2 tablet

once a day

1 tablet

twice a day

children under 2 years

ask a doctor

ask a doctor

Do Not Use (Do not use)
  • this product if you are presently taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
Package Label

Other Information (Other information)
  • each tablet contains: calcium 20 mg, sodium 6 mg (VERY LOW SODIUM)
  • store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow#10 aluminum lake, FD&C yellow#6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-MEDLINE (633-5463)

Monday-Friday 9AM-5PM CST

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and foreign materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: OTCM00011

V1 RE22HND

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

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))
  • Docusate sodium 50 mg
  • Sennosides 8.6 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel movements that persists over 2 weeks

Advanced Ingredient Data


Raw Label Data

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