Senna-Doc: Package Insert and Label Information

SENNA-DOC- sennosides and docusate sodium tablet, coated
3014704014

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 ingredients Purpose (in each tablet) Purpose

Docusate sodium 50 mg…………………………………Stool softner

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

Uses

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

Warnings

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • 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

  • adults and children 12 years of age or olderstarting dosage: 2 tablets once a day, maximum dosage: 4 tablets twice a day
  • children 6 to under 12 yearsstarting dosage: 1 tablet once a day, maximum dosage: 2 tablets twice a day
  • children 2 to under 6 yearsstarting dosage: 1/2 tablet once a day, maximum dosage: 1 tablet twice a day
  • children under 2 yearsstarting dosage: ask a doctor, maximum dosage: ask a doctor

Other information

  • each tablet contains: calcium 21 mg
  • each tablet contains: sodium 3 mg VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, D&C Yellow # 10, FD&C Yellow # 6, hypromellose, microcrystalline cellulose, magnesium stearate, maltodextrin, polyethylene glycol, stearic acid, titanium dioxide

Questions or comments?

Call toll free 1-844-384-3723 Monday through Friday 9AM – 5PM EST or www.safrelpharma.com

PRINCIPAL DISPLAY PANEL

Compare to Senokot-S® Active Ingredients

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®.

Senna and Docusate Sodium Tablets, 8.6 mg and 50 mg

sennadoc
(click image for full-size original)
SENNA-DOC
senna and docusate sodium tablets, 8.6 mg and 50 mg tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71309-113
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
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
MALTODEXTRIN
POLYETHYLENE GLYCOL 1000
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color orange Score no score
Shape ROUND Size 10mm
Flavor Imprint Code S35
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71309-113-25 25 POUCH in 1 BOX contains a POUCH
1 2 TABLET, COATED in 1 POUCH This package is contained within the BOX (71309-113-25)
2 NDC:71309-113-50 50 POUCH in 1 BOX contains a POUCH
2 2 TABLET, COATED in 1 POUCH This package is contained within the BOX (71309-113-50)
3 NDC:71309-113-02 2 POUCH in 1 POUCH contains a POUCH
3 2 TABLET, COATED in 1 POUCH This package is contained within the POUCH (71309-113-02)
4 NDC:71309-113-10 1000 BOTTLE in 1 BOTTLE contains a BOTTLE (71309-113-05)
4 NDC:71309-113-05 500 BOTTLE in 1 BOTTLE This package is contained within the BOTTLE (71309-113-10) and contains a BOTTLE (71309-113-24)
4 NDC:71309-113-24 24 CARTON in 1 BOTTLE This package is contained within the BOTTLE (71309-113-05) and contains a CARTON
4 1 TABLET, COATED in 1 CARTON This package is contained within a BOTTLE (71309-113-24) and a BOTTLE (71309-113-05) and a BOTTLE (71309-113-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 03/07/2016
Labeler — 3014704014 (080566287)

Revised: 01/2020 3014704014

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