Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 08d80e96-c605-40d5-bfb3-e5758daeec80
Route
ORAL
Published
Effective Date 2019-04-15
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 NOT FINAL Active Since 2019-04-15

Description

Sennosides from Senna Concentrate 8.6mg Docusate Sodium 50mg

Purpose

Laxative Stool softner


Medication Information

Purpose

Laxative

Stool softner

Description

Sennosides from Senna Concentrate 8.6mg Docusate Sodium 50mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6-12 hours
Section 51945-4

NDC 66424-378-02

* Compare to the active ingredients in Senokot-S ®

Senna Plus

Natural Vegetable laxative

Ingredient Plus Stool Softener

SENNOSIDES 8.6 mg &

DOCUSATE SODIUM 50mg

SDA LABORATORIES

20 Tablets Free!!

120 Tablets

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
  • if you are taking mineral oil, unless directed by a doctor
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 10 mg of calcium, sodium 5 mg
  • store at 25°(77°F); excursions permitted between 15o-30oC (59o-86oF)
  • Tamper Evident: do not use if safety seal under cap is broken or missing
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 Or Comments?

(800) 687-0176 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 healthcare professional before use. 

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Active Ingredients (in Each Tablet)

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

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
Section 51945-4 (51945-4)

NDC 66424-378-02

* Compare to the active ingredients in Senokot-S ®

Senna Plus

Natural Vegetable laxative

Ingredient Plus Stool Softener

SENNOSIDES 8.6 mg &

DOCUSATE SODIUM 50mg

SDA LABORATORIES

20 Tablets Free!!

120 Tablets

Purpose

Laxative

Stool softner

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
  • if you are taking mineral oil, unless directed by a doctor
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 10 mg of calcium, sodium 5 mg
  • store at 25°(77°F); excursions permitted between 15o-30oC (59o-86oF)
  • Tamper Evident: do not use if safety seal under cap is broken or missing
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 Or Comments? (Questions or comments?)

(800) 687-0176 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 healthcare 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 immediately.

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

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

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)