OTC Medication Information: SENNA

SENNA- sennosides capsule, gelatin coated
CVS

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 Facts

Active ingredient (in each softgel) Purpose

Sennosides 8.6 mg……………………………………………………..Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6-12 hours

Warnings

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
  • nausea
  • vomiting
  • 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

  • take preferably at bedtime or as directed by a doctor
Age Starting Dosage Maximum Dosage
adults and children 12 years of age or older 2 softgels once a day 4 softgels twice a day
children 6 to under 12 years 1 softgel once a day 2 softgels twice a day
children under 6 years of age ask a doctor ask a doctor

Other information

  • each softgel contains: calcium 1 mg and sodim less than 1 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No.6, gelatin, glycerin, light liquid paraffin, purified water, sodium carboxymethyl cellulose, sorbitol solution, soya lecithin, titanium dioxide

Questions?

Call 1-888-333-9792

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL — CVS SENNA 60 Softgels Bottle Carton

♥CVS Health

Compare to the active
ingredient in Senokot ® *

Liquid Filled Softgels†

NDC 69842-320-60

Senna SENNOSIDES, 8.6 mg
Laxative

Standardized senna concentrate

Natural vegetable

laxative ingredient

60 SOFTGELS

Actual Product Size

on Bottom Panel

PRINCIPAL DISPLAY PANEL -- CVS SENNA 60 Softgels Bottle Carton
(click image for full-size original)
SENNA
sennosides capsule, gelatin coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-320
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
YELLOW WAX
D&C RED NO. 33
FD&C RED NO. 40
GELATIN
GLYCERIN
MINERAL OIL
WATER
CARBOXYMETHYLCELLULOSE SODIUM
SORBITOL
LECITHIN, SOYBEAN
TITANIUM DIOXIDE
Product Characteristics
Color brown (Opaque) Score no score
Shape CAPSULE (SOFTGEL) Size 12mm
Flavor Imprint Code 458
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-320-60 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (69842-320-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 03/14/2018
Labeler — CVS (062312574)
Registrant — Spirit Pharmaceuticals LLC (179621011)
Establishment
Name Address ID/FEI Operations
MEDGEL PRIVATE LTD 677385498 manufacture (69842-320)

Revised: 12/2019 CVS

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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