SENNA- sennosides syrup SENNA UD- sennosides syrup

Senna UD by

Drug Labeling and Warnings

Senna UD by is a Otc medication manufactured, distributed, or labeled by Patrin Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Sennosides 8.8 mg

Purpose

Laxative

Uses

• Relieves occasional constipation (irregularity)
• Generally causes bowel movement in 6 to 12 hours

Warnings

Do not use laxative products for longer than one week unless directed by a doctor.

Ask a doctor before use if you

• have stomach pain, nausea or vomiting
• notice a change in bowel habits that last over two weeks
• are pregnant or breast feeding

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

Shake well before using. Do not exceed maximum dose.

Take at bedtime or as directed by a doctor.

AGE	USUAL DOSE	MAXIMUM DOSAGE
Adults and children 12 years and older	2-3 teaspoons (10 to 15 mL) once a day	3 teaspoons (15 mL) twice a day
6 to 12 years	1 to 1 1/2 teaspoons (5 to 7.5 mL) once a day	1 1/2 teaspoons (7.5 mL) twice a day
2 to 6 years	1/2 to 3/4 teaspoons (2.5 to 3.75 mL) once a day	3/4 teaspoon (3.75 mL) once a day
under 2 years of age	Consult a doctor

Other Information

Store at controlled room temperature 20-25°C (68-77°F).

Excursions permitted 15-30°C (59-86°F).

Tamper-Evident: Do not use if foil seal over cup is torn or broken.

Inactive Ingredients

Chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water and sucrose

Questions Or Comments?

Call (800) 936 3088. You may also report serious side effects to this phone number.

How Supplied

• A chocolate flavored syrup supplied in the following oral dosage cup:

• NDC: 39328-120-05:NDC: 39328-120-50: 5 mL unit dose cup; Case contains 50 unit dose cups of 5 mL
• NDC: 39328-220-15:NDC: 39328-220-50: 15 mL unit dose cup; Case contains 50 unit dose cups of 15 mL

SPL UNCLASSIFIED SECTION

Patrin Pharma
Skokie, IL 60076
www.patrinpharma.com

Rev 01.0122

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

NDC: 39328-020-08

Senna Syrup
Natural Vegetable
Laxative

8.8mg/5 mL

Alcohol Free Dye Free

8 fl. oz (237 mL)

PATRIN
PHARMA

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

Delivers 5 mL

NDC: 39328-120-05

Senna Syrup

8.8 mg/5 mL

Shake Well

For Institutional Use Only

See Insert

Lot# xxxxxx

Exp: yyyy/mm/dd

Patrin Pharma

Skokie, IL 60076

Rev 03.0124

PRINCIPAL DISPLAY PANEL - 15 mL Cup Label

Delivers 15 mL

NDC: 39328-220-15

Senna Syrup

26.4 mg/15 mL

Shake Well

For Institutional Use Only

See Insert

Lot# xxxxxx

Exp: mm/dd/yyyy

Patrin Pharma

Skokie, IL 60076

Rev 02.0823

INGREDIENTS AND APPEARANCE

SENNA 
sennosides syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39328-020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sennosides (UNII: 3FYP5M0IJX) (Sennosides - UNII:3FYP5M0IJX)	Sennosides	8.8 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sucrose (UNII: C151H8M554)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	CHOCOLATE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39328-020-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M007	10/01/2023

SENNA UD 
sennosides syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39328-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sennosides (UNII: 3FYP5M0IJX) (Sennosides - UNII:3FYP5M0IJX)	Sennosides	8.8 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sucrose (UNII: C151H8M554)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	CHOCOLATE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39328-120-50	5 in 1 CASE	10/01/2023
1		10 in 1 TRAY
1	NDC: 39328-120-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 39328-120-99	10 in 1 CASE	06/03/2024
2		10 in 1 TRAY
2	NDC: 39328-120-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M007	10/01/2023

SENNA UD 
sennosides syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39328-220
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sennosides (UNII: 3FYP5M0IJX) (Sennosides - UNII:3FYP5M0IJX)	Sennosides	26.4 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sucrose (UNII: C151H8M554)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	CHOCOLATE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39328-220-50	5 in 1 CASE	10/01/2023
1		10 in 1 TRAY
1	NDC: 39328-220-15	15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M007	10/01/2023

Labeler - Patrin Pharma, Inc. (806841677)