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Drug Facts
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Reliable-1 Laboratories LLC
Valley Stream, NY 11580
www.reliable1labs.com
516-341-0666 Mon-Fri 8:30am-4:30pm
Senna Syrup
FDA Label NDC 69618-069
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Senna (NDC 69618-069). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each 5 ml teaspoonful)
Sennosides 8.8 mg
Otc - Purpose
Purpose
Laxative
Indications & Usage
Uses
- relieves occasional constipation (irregularity)
- when abdominal pain, nausea or vomiting are present
Warnings
Warnings
Otc - Do Not Use
Do not use
- longer than 1 week unless directed by a doctor
- when abdominal pain, nausea or vomiting are present
Otc - Ask Doctor
Ask a doctor before use if you have noticed a sudden change in bowel movements that continues over a period of 2 weeks
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
Otc - Stop Use
Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.
Otc - Pregnancy Or Breast Feeding
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 overdose, get medical help or contact a Poison Control Center right away 800-222-1222.
Dosage & Administration
Directions Take preferably at bedtime or as directed by a doctor. Shake well before using. Do not exceed recommended dose.
| Age | Starting Dosage | Maximum Dosage |
Adults and children 12 years and older | 2-3 teaspoons once a day | 3 teaspoons twice a day |
| Under 12 years of age | ask a doctor | ask a doctor |
Storage And Handling
Other information
- avoid excessive heat
- store at room temperature 15°-25°C (59°-86°F).
- Tamper-evident: do not use if aluminum foil seal over bottle opening is torn, broken or missing.
Inactive Ingredient
Inactive ingredients chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water and sucrose.
Package Label.Principal Display Panel
NDC 69618-069-58
Reliable-1®
Senna Syrup
Natural Vegetable Laxative
For Gentle Relief of Constipation
Alcohol Free
Natural Chocolate Flavor
8 fl. oz. (237 ml)
* Please review the disclaimer below.
