Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 7fa1c3b4-1922-41b6-9fdf-f45cc1b5e391
Route
ORAL
Published
Effective Date 2024-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg)
Inactive Ingredients
Dibasic Calcium Phosphate Dihydrate Hypromelloses Magnesium Stearate Croscarmellose Sodium Cellulose, Microcrystalline Silicon Dioxide Talc Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: PS23 Shape: round Color: brown Size: 9 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 or 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

anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, magnesium stearate,  microcrystalline cellulose, silicon dioxide, talc, triacetin 

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

†This product is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark Senokot®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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 or 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)

anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, magnesium stearate,  microcrystalline cellulose, silicon dioxide, talc, triacetin 

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

†This product is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark Senokot®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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)