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  5. Label Information: Senna Syrup

FDA Label for Senna Syrup

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. PREGNANCY
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENT
    10. OTC - QUESTIONS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Senna Syrup Product Label

The following document was submitted to the FDA by the labeler of this product Rising Health, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



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
    • AgeStarting DoseMaximum Dose
    Adults and children over 12 years of age10 to 15 mL once a day at bedtime, increase as needed or as directed by a doctor15 mL in the morning and 15 mL at bedtime
    Children under 12 years of age Ask a doctorAsk a doctor


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


Inactive Ingredient



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


Otc - Questions



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


Package Label.Principal Display Panel



Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

FG-38/Iss.: 04/2023

Lid Label

senna-lid-label - senna lid label

senna-lid-label - senna lid label

Case Label


* Please review the disclaimer below.