Active Ingredient(S)
Sennosides 8.6mg
Senna Lax Tablet
FDA Label NDC 76162-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Senna Lax (NDC 76162-005). 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(s), purpose, use(s), do not use, ask a doctor before use if, stop use and ask a doctor if, pregnancy/breastfeeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Laxative
Use(S)
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 6-12 hours
Do Not Use
laxative products for longer than one week unless directed by a doctor
Ask A Doctor Before Use If
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that continues over a period of 2 weeks
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.
Pregnancy/Breastfeeding
ask a health professional before use
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or 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 | 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 50mg
- do not use if safety seal under cap is broken or missing
Storage
- store at 20°C-25°C (68°F-77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide
Principal Display Panel
Senna Lax (371 Senna Lax 1)
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