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

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


Medication Information

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

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

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.

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
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
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

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
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.

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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