Label: CHOCOLATED LAXATIVE- sennosides bar, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 70692-400-10 - Packager: Strive Pharmaceuticals 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 March 1, 2018
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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WARNINGS
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.
When using this product * do not use for a period longer than 1 week.
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.
If pregnant or breast-feeding,ask a health professional before use.
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHOCOLATED LAXATIVE
sennosides bar, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70692-400 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 COW MILK (UNII: 917J3173FT) GLYCERYL LACTOPALMITATE/STEARATE (UNII: 41BQ90M326) SODIUM CHLORIDE (UNII: 451W47IQ8X) SKIM MILK (UNII: 6A001Y4M5A) SUCROSE (UNII: C151H8M554) HYDROGENATED PALM/PALM KERNEL OIL PEG-6 ESTERS (UNII: 8EPU9MJ01K) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) COCOA (UNII: D9108TZ9KG) COCOA BUTTER (UNII: 512OYT1CRR) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) Product Characteristics Color brown Score no score Shape RECTANGLE Size 70mm Flavor CHOCOLATE Imprint Code SC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70692-400-10 10 in 1 PACKAGE; Type 0: Not a Combination Product 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/01/2018 Labeler - Strive Pharmaceuticals Inc. (080028013)