Label: ONLY FOR STIMULANT LAXATIVE- sennosides tablet
- NDC Code(s): 73006-112-41
- Packager: O4 Global Trading Usa, Llc
- 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.
Updated April 25, 2019
If you are a consumer or patient please visit this version.
- DRUG FACTS
- Active ingredient (in each tablet)
Do not use:
• laxative products for longer than 1 week unless directed by a doctor
Ask a doctor before use if you have
• stomach pain
• noticed a sudden change in bowel habits that continue 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 may indicate a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
• do not take more than directed • take with full glass of water
• 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:
- Inactive Ingredients:
- Questions Or Comments ?
SPL UNCLASSIFIED SECTION
Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.
Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING
Tear along perforation push product through foil
INGREDIENTS AND APPEARANCE
ONLY FOR STIMULANT LAXATIVE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73006-112 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Product Characteristics Color brown Score no score Shape ROUND (Biconvex) Size 9mm Flavor Imprint Code S3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73006-112-41 1 in 1 CARTON 03/29/2019 1 4 in 1 BLISTER PACK; 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 03/29/2019 Labeler - O4 Global Trading Usa, Llc (081226861)