Label: LEADER REGULAR STRENGTH CHOCOLATE LAXATIVE SENNOSIDES- sennosides tablet
- NDC Code(s): 70000-0477-1
- Packager: Cardinal Health Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Updated January 25, 2021
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- Active ingredient (in each piece)
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.
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.
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel – Chocolated Laxative Carton Label
INGREDIENTS AND APPEARANCE
LEADER REGULAR STRENGTH CHOCOLATE LAXATIVE SENNOSIDES
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0477 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sennosides (UNII: 3FYP5M0IJX) (Sennosides - UNII:3FYP5M0IJX) Sennosides 15 mg Inactive Ingredients Ingredient Name Strength Cocoa (UNII: D9108TZ9KG) Product Characteristics Color brown (brown) Score score with uneven pieces Shape SQUARE (square) Size 68mm Flavor CHOCOLATE (chocolate) Imprint Code CL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0477-1 2 in 1 CARTON 01/01/2019 1 12 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2019 Labeler - Cardinal Health Inc. (097537435) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions MD, LLC 829739833 MANUFACTURE(70000-0477)