Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID a5994303-c9d0-4c6f-8eb7-5f364aa6ed0f
Route
ORAL
Published
Effective Date 2024-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Mineral Oil

Identifiers & Packaging

Pill Appearance
Imprint: TCL080 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-05

Description

Sennosides 8.6 mg

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6-12 hours
Directions
  • take preferably at bedtime or as directed by a doctor
 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
  • laxative products for longer than 1 week unless directed by a doctor
Product Labeling
CAREONE Senna Laxative
Other Information
  • each tablet contains: calcium 30 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

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

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Senokot®†

Regular Strength

SENNA LAXATIVE

Laxative Sennosides, 8.6 mg

TABLETS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Senokot®.

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

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 (1-800-222-1222) right away.

Active Ingredients (in Each Tablet)

Sennosides 8.6 mg

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

Structured Label Content

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

Laxative

Directions
  • take preferably at bedtime or as directed by a doctor
 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)
  • laxative products for longer than 1 week unless directed by a doctor
Product Labeling
CAREONE Senna Laxative
Other Information (Other information)
  • each tablet contains: calcium 30 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Senokot®†

Regular Strength

SENNA LAXATIVE

Laxative Sennosides, 8.6 mg

TABLETS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Senokot®.

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

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 (1-800-222-1222) right away.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Sennosides 8.6 mg

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 habits that continues over a periodof 2 weeks 

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)