FDA Label for Maximum Strength Laxative
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
-
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Maximum Strength Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Winco Foods Llc. 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
Sennosides USP, 25 mg
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
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