SENNA-PLUS by REMEDYREPACK INC. hst 455b (555)

SENNA-PLUS by

Drug Labeling and Warnings

SENNA-PLUS by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SENNA-PLUS- sennosides and docusate sodium tablet 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

hst 455b (555)

Active ingredient (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

  • relieves occasional constipation (irregularity)
  • this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use for more than one week unless directed by a doctor

Ask a doctor before use if you

  • have abdominal pain, nausea or vomiting
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that lasts over two 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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not exceed 8 tablets in 24 hours

Age
Starting Dose
Maximum Dose
adults and children 12 years of age and older
2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
4 tablets in the morning and 4 tablets at bedtime
children under 12 years
ask a doctor

Other information

  • each tablet contains: calcium 20 mg, sodium 3 mg
  • store at controlled room temperature
    Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • product of India

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

DRUG: SENNA-PLUS

GENERIC: Sennosides and Docusate Sodium

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2790-0

NDC: 70518-2790-1

NDC: 70518-2790-2

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 9 mm

IMPRINT: PSD22

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • SENNOSIDES 8.6mg in 1
  • DOCUSATE SODIUM 50mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • CROSCARMELLOSE SODIUM
  • CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • HYPROMELLOSES
  • FD&C YELLOW NO. 6
  • TITANIUM DIOXIDE
  • TALC
  • SILICON DIOXIDE

MM1

MM2

MM3

SENNA-PLUS 
sennosides and docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70518-2790(NDC: 57896-555)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize9mm
FlavorImprint Code PSD22
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70518-2790-030 in 1 BLISTER PACK; Type 0: Not a Combination Product06/17/202006/23/2020
2NDC: 70518-2790-1100 in 1 BOX01/15/202103/04/2021
2NDC: 70518-2790-21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/17/202003/04/2021
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2023
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.