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Senna-S

Avema Pharma Solutions

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each tablet)

Docusate Sodium 50 mg*

Sennosides 8.6 mg**

Purpose

*Stool softener

**Laxative

Senna-S Uses

  • relieves occasional constipation (irregularity)
  • generally causes 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 continues over a period of 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 be signs of a serious condition.

If pregnant or breast-feeding, ask a health care 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 and older    2 tablets once a day    4 tablets twice a day
   children 6 to under 12 years of age    1 tablet once a day    2 tablets twice a day
   children 2 to 6 years of age    ½ tablet once a day    1 tablet twice a day
   children under 2 years of age    ask a doctor    ask a doctor

Senna-S Other information

  • each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM
  • each tablet contains: calcium 20 mg/tablet
  • store at 15°-30°C (59°-86°F) in well closed containers
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Senokot-S®.

Inactive ingredients

carnauba wax, colloidal silicon dioxide,croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 8000, sodium benzoate, stearic acid, and titanium dioxide. May also contain: maltodextrin, mineral oil, Opadry II Orange, pregelatinized starch, talc, silicon dioxide 50s.

Package/Label Principal Display Panel

Senna-S

NDC 63548-4000-*1

NATURAL LAXATIVE

PLUS STOOL SOFTENER

SENNA-S

DOCUSATE SODIUM, 50 MG

AND SENNOSIDES, 8.6 MG

30 TABLETS


Do not use if imprinted safety seal under cap is broken or missing.

Senna-S

Docusate Sodium and Sennosides TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63548-4001
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 50 mg
SENNOSIDES SENNOSIDES 8.6 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
hypromellose
MAGNESIUM STEARATE
maltodextrin
MEDIUM-CHAIN TRIGLYCERIDES
cellulose, microcrystalline
POLYDEXTROSE
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Shape
ORANGE 4 mm ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63548-4001-1 30 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-01-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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