drug facts

drug facts
SPL v3
SPL
SPL Set ID c0e27b02-8ef2-4239-8f8c-790f7d978dc0
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) docusate (50 mg)
Inactive Ingredients
croscarmellose sodium d&c yellow no. 10 calcium phosphate, dibasic, dihydrate fd&c yellow no. 6 magnesium stearate cellulose, microcrystalline polyvinyl alcohol, unspecified polyethylene glycol, unspecified sodium benzoate talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: PH32 Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2019-07-10

Purpose

Laxative Stool Softener

Description

Sennosides 8.6 mg Docusate Sodium 50 mg


Medication Information

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

Laxative

Stool Softener

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 

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 10 mg, sodium 5 mg, Very Low Sodium
  • store at 20-25°C(68-77°F); excursions permitted between 15 o-30 oC (59 o-86 oF)
Inactive Ingredients

croscarmellose sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc, titanium dioxide

Description

Sennosides 8.6 mg Docusate Sodium 50 mg

Questions?

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

Section 51945-4

PHARBEST

NDC 73057-378-11

Manufactured in the USA

*Compare to the active ingredients in Senokot-S ®

SENNA-S

Sennosides 8.6 mg &

Docusate Sodium 50 mg

Natural Vegetable Laxative

Ingredient Plus Stool Softener

1000 TABLETS

Do Not Use
  • if you are taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
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).

Active Ingredients (in Each Tablet)

Sennosides 8.6 mg

Docusate Sodium 50 mg

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

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

Laxative

Stool Softener

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 

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 10 mg, sodium 5 mg, Very Low Sodium
  • store at 20-25°C(68-77°F); excursions permitted between 15 o-30 oC (59 o-86 oF)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc, titanium dioxide

Questions?

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

Section 51945-4 (51945-4)

PHARBEST

NDC 73057-378-11

Manufactured in the USA

*Compare to the active ingredients in Senokot-S ®

SENNA-S

Sennosides 8.6 mg &

Docusate Sodium 50 mg

Natural Vegetable Laxative

Ingredient Plus Stool Softener

1000 TABLETS

Do Not Use (Do not use)
  • if you are taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
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).

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

Sennosides 8.6 mg

Docusate Sodium 50 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 period of 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)