SPL v4
SPL
SPL Set ID 802cc573-dee7-47ce-bf9a-0b2b886601d7
Route
ORAL
Published
Effective Date 2025-07-08
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 2023-05-23
Description

Senna Syrup (8.8 mg/5 mL) Active ingredient per 5 mL(1 Unit Dose) 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 vomiting
  • noticed a change in bowel habits that lasts over two weeks

Stop 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 use
  • do not exceed recommended dose
Age Starting Dose Maximum Dose
Adults and children over 12 years of age 10 to 15 mL once a day at bedtime, increase as needed or as directed by a doctor 15 mL in the morning and 15 mL at bedtime
Children under 12 years of age  Ask a doctor Ask a doctor

Description

Senna Syrup (8.8 mg/5 mL) Active ingredient per 5 mL(1 Unit Dose) Sennosides 8.8 mg

Section 42228-7

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

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Section 51727-6

Inactive ingredients  flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose.

Section 51945-4

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

FG-38/Iss.: 04/2023

Lid Label

Case Label

Section 53413-1

Questions or comments?  Call 1-844-474-7464

Section 55105-1

Drug Facts

Purpose

Laxative

Section 55106-9

Senna Syrup (8.8 mg/5 mL)

Active ingredient per 5 mL(1 Unit Dose) Sennosides 8.8 mg

Other Information

• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

• do not use if lid is torn or broken

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 use
  • do not exceed recommended dose
Age Starting Dose Maximum Dose
Adults and children over 12 years of age 10 to 15 mL once a day at bedtime, increase as needed or as directed by a doctor 15 mL in the morning and 15 mL at bedtime
Children 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 vomiting
  • noticed a change in bowel habits that lasts over two weeks

Stop 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 healthcare professional before use.

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 right away (1-800-222-1222)

Section 51727-6 (51727-6)

Inactive ingredients  flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose.

Section 51945-4 (51945-4)

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

FG-38/Iss.: 04/2023

Lid Label

Case Label

Section 53413-1 (53413-1)

Questions or comments?  Call 1-844-474-7464

Section 55105-1 (55105-1)

Drug Facts

Purpose

Laxative

Section 55106-9 (55106-9)

Senna Syrup (8.8 mg/5 mL)

Active ingredient per 5 mL(1 Unit Dose) Sennosides 8.8 mg

Other Information (Other information)

• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

• do not use if lid is torn or broken

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:28.395710 · Updated: 2026-03-14T23:09:15.187219