Label: CAREALL SENNOSIDES- sennosides tablet
- NDC Code(s): 51824-058-01
- Packager: New World Imports, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 14, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Keep out of Reach of Children
Do not use laxative products for more than one week unless directed by a doctor
Ask a doctor before use if you have stomach pains, nausea, vomiting, notice a sudden change in bowel habits that continues over a period of 2 weeks.
Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative. These could be signs of a serious condition.
If Pregnant or breast-feeding ask a health professional before use.
Take preferably at bedtime or as directed by a doctor.
Adults and children over 12 years: 2 tablets once a day. Maximum of 4 tablets twice a day.
Children 6 to under 12 years: 1 tablet once a day. Maximum of 2 tablets twice a day.
Children 2 to under 6 years: 1/2 tablet once a day. Maximum of 1 tablet twice a day.
Children under 2: consult a doctor
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-058 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sennosides a and b (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) sennosides a and b 8.6 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Croscarmellose Sodium (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) Magnesium stearate (UNII: 70097M6I30) Cellulose, microcrystalline (UNII: OP1R32D61U) Product Characteristics Color brown (Speckled various shades of brown) Score no score Shape ROUND (Round) Size 8mm Flavor Imprint Code AZ;217 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-058-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/18/2016 Labeler - New World Imports, Inc (075372276)