Active Ingredient (In Each Tablet)
Sennosides 8.6 mg
Senna Laxative Tablet
FDA Label NDC 0761-0798
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Basic Drugs, Inc. for the product Senna Laxative (NDC 0761-0798). 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 active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6-12 hours
Warnings
Do not use
- laxative products for longer than 1 week unless directed by a doctor
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that continues over a period of 2 weeks
Ask a doctor before use if you have
Stop use and ask a doctor ifyou have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.
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 (1-800-222-1222) right away.
Directions
• take preferably at bedtime or as directed by a doctor
age | starting dosage | maximum dosage |
adults and children 12 years of age and over | 2 tablets once a day | 4 tablets twice a day |
children 6 to under 12 years | 1 tablet once a day | 2 tablets twice a day |
children 2 to under 6 years | 1/2 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 25 mg
- store at room temperature
- DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, hypromellose, liquid paraffin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate, stearic acid.
Questions?
937-898-4010
Package Label
1 (Label)
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