Other
Drug Facts
Patrin Pharma
Skokie, IL 60076
www.patrinpharma.com
Rev 01.0122
Senna Syrup
FDA Label NDC 39328-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Patrin Pharma, Inc. for the product Senna (NDC 39328-020). 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 other, active ingredient (in each 5 ml = 1 teaspoonful), purpose, uses, otc - do not use, ask a doctor before use if you, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml = 1 Teaspoonful)
Sennosides 8.8 mg
Purpose
Laxative
Uses
- Relieves occasional constipation (irregularity)
- Generally causes bowel movement in 6 to 12 hours
Otc - Do Not Use
Do not use laxative products for longer than one week unless directed by a doctor.
Ask A Doctor Before Use If You
- have stomach pain, nausea or vomiting
- notice a change in bowel habits that last over two weeks
- are pregnant or breast feeding
Otc - Stop Use
Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after 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 immediately.
Directions
Shake well before using. Do not exceed maximum dose.
Take at bedtime or as directed by a doctor.
| AGE | USUAL DOSE | MAXIMUM DOSAGE |
|---|---|---|
| Adults and children 12 years and older | 2-3 teaspoons (10 to 15 mL) once a day | 3 teaspoons (15 mL) twice a day |
| 6 to 12 years | 1 to 1 1/2 teaspoons (5 to 7.5 mL) once a day | 1 1/2 teaspoons (7.5 mL) twice a day |
| 2 to 6 years | 1/2 to 3/4 teaspoons (2.5 to 3.75 mL) once a day | 3/4 teaspoon (3.75 mL) once a day |
| under 2 years of age | Consult a doctor | |
Other Information
Store at controlled room temperature 20-25°C (68-77°F).
Excursions permitted 15-30°C (59-86°F).
Tamper-Evident: Do not use if foil seal over cup is torn or broken.
Inactive Ingredients
Chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water and sucrose
Questions Or Comments?
Call (800) 936 3088. You may also report serious side effects to this phone number.
How Supplied
- A chocolate flavored syrup supplied in the following oral dosage cup:
| NDC 39328-120-05: NDC 39328-120-50: | 5 mL unit dose cup Case contains 50 unit dose cups of 5 mL |
| NDC 39328-220-15: NDC 39328-220-50: | 15 mL unit dose cup Case contains 50 unit dose cups of 15 mL |
Principal Display Panel - 237 Ml Bottle Label
NDC 39328-020-08
Senna Syrup
Natural Vegetable
Laxative
8.8mg/5 mL
Alcohol Free • Dye Free
8 fl. oz (237 mL)
PATRIN
PHARMA
Principal Display Panel (237 mL Bottle Label)
Principal Display Panel - 5 Ml Cup Label
Delivers 5 mL
NDC 39328-120-05
Senna Syrup
8.8 mg/5 mL
Shake Well
For Institutional Use Only
See Insert
Lot# xxxxxx
Exp: yyyy/mm/dd
Patrin Pharma
Skokie, IL 60076
Rev 03.0124
Principal Display Panel (5 mL Cup Label)
Principal Display Panel - 15 Ml Cup Label
Delivers 15 mL
NDC 39328-220-15
Senna Syrup
26.4 mg/15 mL
Shake Well
For Institutional Use Only
See Insert
Lot# xxxxxx
Exp: mm/dd/yyyy
Patrin Pharma
Skokie, IL 60076
Rev 02.0823
Principal Display Panel (15 mL Cup Label)
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