Senna Syrup

Senna Syrup
SPL v1
SPL
SPL Set ID a9f1ef8d-8700-481f-a709-972bb9d27153
Route
ORAL
Published
Effective Date 2024-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.8 mg)
Inactive Ingredients
Methylparaben Propylene Glycol Propylparaben Water Sucrose

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

Drug Facts

Purpose

Laxative

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


Medication Information

Purpose

Laxative

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
Description

Drug Facts

Uses
  • Relieves occasional constipation (irregularity)
  • Generally causes bowel movement in 6 to 12 hours
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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

Section 50570-1

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

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.

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
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

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

Active Ingredient (in Each 5 Ml = 1 Teaspoonful)

Sennosides 8.8 mg


Structured Label Content

Uses
  • Relieves occasional constipation (irregularity)
  • Generally causes bowel movement in 6 to 12 hours
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50570-1 (50570-1)

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

Purpose

Laxative

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
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
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.

Ask A Doctor Before Use If You (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
Principal Display Panel 5 Ml Cup Label (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 (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

Principal Display Panel 237 Ml Bottle Label (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

Active Ingredient (in Each 5 Ml = 1 Teaspoonful) (Active ingredient (in each 5 mL = 1 teaspoonful))

Sennosides 8.8 mg


Advanced Ingredient Data


Raw Label Data

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