Senna Syrup Liquid
FDA Label NDC 57237-310

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Senna Syrup (NDC 57237-310). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, pregnancy, otc - keep out of reach of children, dosage & administration, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Pregnancy

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Other Information

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Otc - Active Ingredient

Senna Syrup (8.8 mg/5 mL)

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

Otc - Purpose

Drug Facts

Purpose

Laxative

Indications & Usage

Uses

relieves occasional constipation (irregularity)
generally causes bowel movement in 6 to 12 hours

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.

Pregnancy

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

Otc - Keep Out Of Reach Of Children

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)

Dosage & 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