986 senna

986 senna
SPL v6
SPL
SPL Set ID 9a6240f3-398c-06b8-e053-2995a90a73df
Route
oral
Published
Effective Date 2022-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides a and b (8.6 mg)
Inactive Ingredients
croscarmellose dibasic calcium phosphate dihydrate hypromellose, unspecified magnesium stearate microcrystalline cellulose mineral oil

Identifiers & Packaging

Pill Appearance
Imprint: TCL080 Shape: round Color: brown Size: 9 mm
Marketing Status
otc monograph drug active Since 2019-01-01

Purpose

Stimulant laxative

Description

Sennosides 8.6 mg


Medication Information

Active Ingredient

Sennosides 8.6 mg

Uses
  • relieves occational constipation (irregularity)
  • generally causes bowel movement in 6-12 hours
Purpose

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 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

Other Information
  • each tablet contains: calcium 25 mg, sodium 2 mg. (VERY LOW SODIUM)
  • store at 25°C (77°F), excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Description

Sennosides 8.6 mg

Do Not Use
  • laxative products for longer than 1 week unless directed by a doctor
Package Label

Questions Or Comments?

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

Monday-Friday 9AM-5PM CST

Manufacturing Information

Manufactured by:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in the USA with U.S. and Foreign Components

www.medline.com

1-800-MEDLINE (633-5463)

REF: OTCM00007

V2 RH22HND

Stop Use and Ask A Doctor If

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

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Sennosides 8.6 mg

Uses
  • relieves occational constipation (irregularity)
  • generally causes bowel movement in 6-12 hours
Purpose

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 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

Other Information (Other information)
  • each tablet contains: calcium 25 mg, sodium 2 mg. (VERY LOW SODIUM)
  • store at 25°C (77°F), excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Do Not Use (Do not use)
  • laxative products for longer than 1 week unless directed by a doctor
Package Label

Questions Or Comments? (Questions or comments?)

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

Monday-Friday 9AM-5PM CST

Manufacturing Information

Manufactured by:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in the USA with U.S. and Foreign Components

www.medline.com

1-800-MEDLINE (633-5463)

REF: OTCM00007

V2 RH22HND

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 may indicate 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks

Advanced Ingredient Data


Raw Label Data

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