Laxative
FDA Label NDC 11822-1572
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Laxative (NDC 11822-1572). 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 drug facts, active ingredient (in each softgel), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Docusate sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Laxative
Uses
• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours
Otc - Do Not Use
Do not use • if you are now taking mineral oil, unless directed by a doctor • laxative products for longer than 1 week, unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that continues over a period of 2 weeks
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.
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 could be signs of a serious condition • you need to use a stool softener
laxative for more than 1 week
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. (1-800-222-1222)
Directions
take preferably at bedtime or as directed by a doctor
| Age | Starting Dosage | Maximum Dosage |
| adults & children 12 years of age & over | 2 tablets once a day | 4 tablets twice a day |
| children 6 to under 12 years of age | 1 tablet once a day | 2 tablets twice a day |
| children 2 to under 6 years | ½ tablet once a day | 1 tablet twice a day |
| children under 2 years | ask a doctor | ask a doctor |
Other Information
• each tablet contains: calcium 2 mg and sodium 6 mg
• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F)
Inactive Ingredients
Light liquid paraffin, Soya lecithin, Beeswax, Colloidal silicon dioxide (aerosol), Sodium Carboxymethyl Cellulose, titanium dioxide, Gelatin, Glycerin, Sorbitol sorbitan, Povidone, FD&C Yellow-6, FD&C Red-33, spl, Purified water
Questions Or Comments?
1-888-333-9792
Other
Distributed by:
RITE AID
30 Hunter Lane, Camp Hill, PA 17011
www.riteaid.com
Made in India
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