Stool Softener description, usages, side effects, indications, overdosage, supplying and lots more!

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Stool Softener

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

**Stimulant laxative

Stool Softener Uses

relief of occasional constipation (irregularity). This product generally produces a bowel movement within 6 to 12 hours.

Warnings

Ask a doctor before use if you have

  • stomach
  • pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts over a period of 2 weeks

Ask a doctor or pharmacist before use if you are presently taking mineral oil.

Stop use and ask a doctor if

  • you need to use a laxative for more than 1 week
  • you have no bowel movement or have rectal bleeding. 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

  • doses may be taken as a single dose or in divided doses preferably in the evening
adults and children 12 years of age and older take 2-4 tablets daily
children 6 to under 12 years of age take 1-2 tablets daily
children 2 to 6 years of age take up to 1 tablet daily
children under 2 years of age ask a doctor

Stool Softener 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), protect from excessive moisture
  • 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 Peri-Colace®.

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Red #40 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, sodium benzoate, stearic acid, and titanium dioxide. May also contain: ethanol, FD&C Blue # 2 Aluminum Lake, maltodextrin, mineral oil, Opadry ll Red, pregelatinized starch, silicon dioxide 50s.

Package/Label Principal Display Panel

Stool Softener

NDC 63548-4000-*1

Compare to the active ingredients of Peri-Colace®*

STOOL SOFTENER PLUS STIMULANT LAXATIVE

DOCUSATE SODIUM, 50 MG

PLUS SENNOSIDES, 8.6 MG

For Relief of Occasional Constipation

100 TABLETS

Stool Softener

Docusate Sodium and Sennosides TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63548-4000
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 BLUE NO. 2
FD&C RED NO. 40
hypromellose
MAGNESIUM STEARATE
maltodextrin
MEDIUM-CHAIN TRIGLYCERIDES
cellulose, microcrystalline
POLYDEXTROSE
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Shape
RED 4 mm ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63548-4000-1 100 in 1 BOTTLE, PLASTIC

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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