SPL v2
SPL
SPL Set ID dc636b83-6eca-412e-bac5-0c736b371ca7
Route
ORAL
Published
Effective Date 2024-10-18
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

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-27

Description

Senna Syrup Active ingredient (in each 5 mL teaspoonful) Sennosides - 8.8 mg


Medication Information

Warnings and Precautions

Warnings

Do not use laxative products for longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

  • stomach pain, nausea or vomitting
  • noticed a change in bowel habits that lasts over two weeks.

Stope use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use of laxative. These may indicate a serious condition.

Indications and Usage

Uses

  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6 to 12 hours
Dosage and Administration

Directions

  • shake well before using
  • Do not exceed recommended dose
Age Starting Dose Maximum Dose
 adults and children 12 years and older  2 to 3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 teaspoonfuls in the morning and 3 teaspoonfuls at bedtime
Under 12 years of age  ask a doctor  ask a doctor

Description

Senna Syrup Active ingredient (in each 5 mL teaspoonful) Sennosides - 8.8 mg

Section 42228-7

If pregnant or breast-feeding, ask a health professional before use.

Section 44425-7

Other information

  • store at room temperature 15° to 25° C (59° to 77° F)

TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken, or missing.

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 51727-6

Inactive ingredients: artificial and natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose.

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-844-474-7464

Section 55105-1

Purpose

Laxative

Section 55106-9

Senna Syrup

Active ingredient

(in each 5 mL teaspoonful)

Sennosides - 8.8 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6 to 12 hours
Dosage and Administration (34068-7)

Directions

  • shake well before using
  • Do not exceed recommended dose
Age Starting Dose Maximum Dose
 adults and children 12 years and older  2 to 3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 teaspoonfuls in the morning and 3 teaspoonfuls at bedtime
Under 12 years of age  ask a doctor  ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use laxative products for longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

  • stomach pain, nausea or vomitting
  • noticed a change in bowel habits that lasts over two weeks.

Stope use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use of laxative. These may indicate a serious condition.

Section 42228-7 (42228-7)

If pregnant or breast-feeding, ask a health professional before use.

Section 44425-7 (44425-7)

Other information

  • store at room temperature 15° to 25° C (59° to 77° F)

TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken, or missing.

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 51727-6 (51727-6)

Inactive ingredients: artificial and natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-844-474-7464

Section 55105-1 (55105-1)

Purpose

Laxative

Section 55106-9 (55106-9)

Senna Syrup

Active ingredient

(in each 5 mL teaspoonful)

Sennosides - 8.8 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)