Senna Solution
FDA Label NDC 0536-1483

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Senna (NDC 0536-1483). 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 active ingredient                         purpose, uses, warnings, ask a doctor before use if you:, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                         Purpose

(per 5 mL teaspoon)

Sennosides 8.8 mg .............. Laxative

Uses

  • Relieves occasional constipation (irregularity)
  • Generally causes bowel movements in 6-12 hours

Warnings

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

Ask A Doctor Before Use If You:

  • have stomach pain, nausea, or vomiting 
  • notice a change in bowel habits that last over 2 weeks 
  • are pregnant or breastfeeding. 

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 immediately (800-222-1222).

Directions

  • Shake well before using.
  • Do not exceed maximum dose.
  • Take at bedtime or as directed by a doctor.

    • AGE

    USUAL DOSE

    MAXIMUM DOSE

    Adults & children 12 years & older

    2 to 3 teaspoons (10 mL to 15 mL) once a day

    3 teaspoons (15 mL) twice a day

    Under 12 years

    Consult a doctor

Other Information

Store at controlled room temperature 68° to 77°F (20° to 25°C). Excursions permitted 59° to 86°F (15° to 30°C).

Inactive Ingredients

Chocolate flavor, methyl paraben, propylene glycol, propyl paraben, brownie flavor, purified water and sucrose.

Principal Display Panel

NDC 0536-1483-59

senna
liquid

sennosides 8.8 mg per 5 mL

8 fl oz (237 mL)

Containerlabel (Containerlabel)

Containerlabel (Containerlabel)

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