drug facts

drug facts
SPL v3
SPL
SPL Set ID 485129a0-8340-4f61-be51-5abff5032b8d
Route
oral
Published
Effective Date 2019-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides (8.6 mg)
Inactive Ingredients
calcium phosphate, dibasic, anhydrous hypromellose, unspecified magnesium stearate cellulose, microcrystalline mineral oil talc triacetin croscarmellose sodium

Identifiers & Packaging

Pill Appearance
Imprint: S8 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2019-07-10

Purpose

Laxative

Description

Sennosides 8.6mg


Medication Information

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
Active Ingredient

Sennosides 8.6mg

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 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

½ 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  31 mg, sodium 2 mg, Very Low Sodium
  • store at 20 0-25 0C (68 0-77 0F); excursions permitted between 15 0-30 0C (59 0-86 0F)
Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, talc, triacetin

Description

Sennosides 8.6mg

Section 51945-4

PHARBEST

NDC 73057-363-11

Manufactured in the USA

*Compare to the active ingredient of Senokot ®

Senna-Tabs

Natural Vegetable Laxative Ingredient

1000 TABLETS

8.6 mg each

Questions Or Comments?

(866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)

Stop Use and Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after the 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 (1-800-222-1222).

Ask A Doctor Before Use 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

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
Active Ingredient (Active ingredient (in each tablet))

Sennosides 8.6mg

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 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

½ 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  31 mg, sodium 2 mg, Very Low Sodium
  • store at 20 0-25 0C (68 0-77 0F); excursions permitted between 15 0-30 0C (59 0-86 0F)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, talc, triacetin

Section 51945-4 (51945-4)

PHARBEST

NDC 73057-363-11

Manufactured in the USA

*Compare to the active ingredient of Senokot ®

Senna-Tabs

Natural Vegetable Laxative Ingredient

1000 TABLETS

8.6 mg each

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon - Fri 8 AM to 4 PM 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 the 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 (1-800-222-1222).

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 period of 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)