drug facts

drug facts
SPL v2
SPL
SPL Set ID 1959ef47-95c1-4234-9e1c-ad679b8dfb77
Route
oral
Published
Effective Date 2024-07-31
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 silicon dioxide talc triacetin

Identifiers & Packaging

Pill Appearance
Imprint: P23 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-05-31

Purpose

Laxative

Description

Sennosides 8.6 mg


Medication Information

Active Ingredient

Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a 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 tablets once a day  1 tablet twice a day
 children under 2 years  ask a doctor  ask a doctor




Other Information
  • each tablet contains: calcium 30 mg
  • store at 25o C (77o F); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

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

Description

Sennosides 8.6 mg

Principal Display Panel

*Compare to the Active Ingredient in Senokot®

Laxative Regular Strength

Laxative

Sennosides 8.6 mg

Natural Vegetable Laxative Ingredient

Provides Gentle Relief of:

Occasional Constipation

Tablets

*This product is not manufactured or distributed by Aviro Health L.P., distributor of 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 CDMA, Inc.

Novi, MI 48375

Do Not Use
  • laxative products for longer than 1 week unless directed by a doctor
Product Label
QUALITY CHOICE Regular Strength Laxative
Questions Or Comments?

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

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.

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

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a 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 tablets 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 30 mg
  • store at 25o C (77o F); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

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

Principal Display Panel

*Compare to the Active Ingredient in Senokot®

Laxative Regular Strength

Laxative

Sennosides 8.6 mg

Natural Vegetable Laxative Ingredient

Provides Gentle Relief of:

Occasional Constipation

Tablets

*This product is not manufactured or distributed by Aviro Health L.P., distributor of 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 CDMA, Inc.

Novi, MI 48375

Do Not Use (Do not use)
  • laxative products for longer than 1 week unless directed by a doctor
Product Label
QUALITY CHOICE Regular Strength Laxative
Questions Or Comments? (Questions or comments?)

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

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.

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

Advanced Ingredient Data


Raw Label Data

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