FDA Label for Senna
View Indications, Usage & Precautions
Senna Product Label
The following document was submitted to the FDA by the labeler of this product Pai Holdings, Llc Dba Pai Pharma. 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
Active ingredient (per teaspoonful - 5 mL)
Sennosides - 8.8 mg
Otc - Purpose
Purpose
Laxative
Indications & Usage
Uses
- relieves occasional constipation (irregularity)
- generally causes bowel movment in 6 to 12 hours
Warnings
Warnings
Do not use
- laxative products for longer than 1 week unless directed by a doctor
- stomach pain
- nausea
- vomiting
- noticed a sudden changed in bowel movement that continues over a period of 2 weeks
Ask a doctor or pharmacis before use if you have
Stop use and ask a doctor if
you have rectal bleeding or failure to have a bowel movemebt after use of laxative. They may indicate a serious condition.
Pregnancy
If pregnant or breast-feeding ask a health 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 (1-800-222-1222) immediately.
Dosage & Administration
- shake well before use
- Do not exceed recommended dose
- store at room temperature 20° to 25°C (68° to 77°F).
- a brown, natural flavored syrup supplied in the following oral dosage form:
| Age | Starting Dose | Maximum dosage |
| Adults and children 12 years and older | 2-3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor | 3 teaspoons in the morning and 3 teaspoons at bedtime |
| Under 12 years of age | ask a doctor | ask a doctor |
Other information
NDC 0121-4967-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-4967-40: Case contains 40 unit dose cups of 5 mL (0121-4967-05) packaged in 4 trays of 10 unit dose cups each.
Inactive Ingredient
Inactive ingredients: citric acid, glycerin, methylparaben, potassium sorbate, propylparaben, purified water, and sucrose.
Otc - Questions
Questions or comments? 1-800-845-8210
Other
Distributed By:
Pharmaceutical Associates, Inc.
Greenville, SC 29605
Package Label.Principal Display Panel
Delivers
5 mL
NDC 0121-4967-05
Senna Syrup
8.8 mg Sennosides/5 mL
Natural Vegetable Laxative
Package Not Child-Resistant
Pharmacutical Associates, Inc.
Greenville, SC 29605
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