OTC Medication Information: Senna-S

SENNA-S- sennosides and docusate sodium tablet
STRATEGIC SOURCING SERVICES LLC

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.

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 1 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 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.

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 6 mg
  • store at room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, D&C yellow #10, FD&C
yellow #6, hypromellose, magnesium stearate, PEG, silica,
sodium benzoate, stearic acid, titanium dioxide, wax.

Package Label

455
(click image for full-size original)

SENNA-S
sennosides and docusate sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0364
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSES
FD&C YELLOW NO. 6
SODIUM BENZOATE
STEARIC ACID
TITANIUM DIOXIDE
CARNAUBA WAX
D&C YELLOW NO. 10
SILICON DIOXIDE
Product Characteristics
Color orange Score no score
Shape ROUND Size 9mm
Flavor Imprint Code TCL081
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62011-0364-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET in 1 BOTTLE This package is contained within the CARTON (62011-0364-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 02/01/2016 11/01/2021
Labeler — STRATEGIC SOURCING SERVICES LLC (116956644)
Registrant — Geri-Care Pharmaceutical Corp (611196254)
Establishment
Name Address ID/FEI Operations
Geri-Care Pharmaceutical Corp 611196254 repack (62011-0364)

Revised: 12/2019 STRATEGIC SOURCING SERVICES LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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