Otc - Active Ingredient
Sennosides USP, 25 mg
Maximum Strength Laxative
FDA Label NDC 67091-383
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 Maximum Strength Laxative (NDC 67091-383). 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, , 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
Stimulant Laxative
Indications & Usage
Uses
• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6 to 12 hours
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 40 mg, sodium 2 mg (VERY LOW SODIUM)
• store between 20°-25°C (68°-77°F).
Inactive Ingredient
Inactive ingredients
acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminium lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide
Otc - Questions
Questions? Call 1-800-824-1706 Monday- Friday 9am-4pm MST
Package Label.Principal Display Panel
195r-winco-max-strength-laxative-carton-24s (195r Winco Max Strength Laxative Carton 24s)
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