Label: SENNOSIDES tablet, film coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 70518-3387-0, 70518-3387-1, 70518-3387-2, 70518-3387-3 - Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 70000-0447
- 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 17, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- Uses
-
WARNINGS
Ask a doctor before use if you have
■ stomach pain
■ nausea
■ vomiting
■ noticed a sudden change in bowel habits that continues over a period of 2 weeks
-
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 tablet twice a day
children 6 to under 12 years
1 tablets once a day
2 tablets once 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 INGREDIENT
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL
DRUG: Sennosides
GENERIC: Sennosides
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-3387-0
NDC: 70518-3387-1
NDC: 70518-3387-2
NDC: 70518-3387-3
COLOR: brown
SHAPE: ROUND
SCORE: No score
SIZE: 9 mm
IMPRINT: 1122;1122
PACKAGING: 1 in 1 POUCH
OUTER PACKAGING: 100 in 1 BOX
PACKAGING: 1 in 1 POUCH
OUTER PACKAGING: 100 in 1 BOX
ACTIVE INGREDIENT(S):
- SENNOSIDES 8.6mg in 1
INACTIVE INGREDIENT(S):
- POLYETHYLENE GLYCOL 400
- MICROCRYSTALLINE CELLULOSE
- HYPROMELLOSES
- MAGNESIUM STEARATE
- CROSCARMELLOSE SODIUM
- LIGHT MINERAL OIL
- TALC
- MALTODEXTRIN
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
-
INGREDIENTS AND APPEARANCE
SENNOSIDES
sennosides tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-3387(NDC:70000-0447) 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 POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LIGHT MINERAL OIL (UNII: N6K5787QVP) TALC (UNII: 7SEV7J4R1U) MALTODEXTRIN (UNII: 7CVR7L4A2D) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) Product Characteristics Color brown Score no score Shape ROUND Size 9mm Flavor Imprint Code 1122;1122 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70518-3387-0 100 in 1 BOX 03/15/2022 1 NDC:70518-3387-1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:70518-3387-2 100 in 1 BOX 03/16/2022 2 NDC:70518-3387-3 1 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 03/15/2022 Labeler - REMEDYREPACK INC. (829572556)