Otc - Active Ingredient
Active ingredient (in each tablet)
Sennosides USP, 25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Laxative (NDC 0363-9978). 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, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each tablet)
Sennosides USP, 25 mg
Purpose
Stimulant laxative
Uses
• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6 to 12 hours
Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks.
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.
When using this product do not use for a period longer than 1 week
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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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: 2 tablets once or twice daily
children 6 to under 12 years of age: 1 tablet once or twice daily
children under 6 years of age: ask a doctor
Other information
•
each tablet contains: calcium 40 mg, sodium 2 mg (VERY LOW SODIUM)
• store between 20°-25°C (68°-77°F)
Inactive ingredients acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum 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.
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