Otc - Active Ingredient
Active ingredient (in each tablet)
Sennosides USP, 15 mg
Regular Strength Laxative
FDA Label NDC 67091-384
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods Llc for the product Regular Strength Laxative (NDC 67091-384). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Stimulant Laxative
Indications & Usage
Uses
• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6 to12 hours
Warnings
Warnings
Otc - Do Not Use
Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have
- noticed a sudden change in bowel habits that persists over a period of 2 weeks
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you
- are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.
Otc - When Using
When using this product
- do not use for a period longer than 1 week
Otc - Stop Use
Stop use and ask a doctor if
- rectal bleeding or failure to have a bowel movement occur after use of a laxative.
These may be signs of 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.
Dosage & Administration
Directions
• Swallow tablet(s) with a glass of water
• Swallow tablet(s) whole, do not crush, break, or chew.
| adults and children 12 years of age and older | take 2 tablets once or twice daily |
| children 6 to under 12 years of age | take 1 tablet once or twice daily |
| children under 6 years of age | ask a doctor |
Other Safety Information
Other information
•
each tablet contains: calcium 50 mg, sodium 2 mg (VERY LOW SODIUM)
• store between 20°-25°C (68°-77°F)
Inactive Ingredient
Inactive ingredient acacia, calcium sulfate anhydrous, carnauba wax, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, shellac, sugar, talc, titanium dioxide
Otc - Questions
Questions? Call
1-800-824-1706
Monday – Friday 9am – 4pm MST
Package Label.Principal Display Panel
190r-winco-regular-strength-carton-24s (190r Winco Regular Strength Carton 24s)
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