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Stool Softener with Laxative by Geri-Care Pharmaceutical Corp

Dosage form: tablet, film coated
Ingredients: SENNOSIDES 8.6mg, DOCUSATE SODIUM 50mg
Labeler: Geri-Care Pharmaceutical Corp
NDC Code: 57896-303

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.

Gericare 303

Active ingredient (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

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

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
  • if you are presently taking mineral oil, 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 could

be signs of 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 only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
adults and children 12 years and overtake 2-4 tablets daily
children under 12 years of ageask a doctor

Other information
  • each tablet contains: calcium 20 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 15°-30°C (59°-86°F), protect from excessive moisture

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, sodium benzoate, stearic acid, titanium dioxide

Questions or comments?

Call toll free 1-800-540-3765

Package Label

STOOL SOFTENER WITH LAXATIVE 
docusate sodium and sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-303
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
POLYETHYLENE GLYCOL, UNSPECIFIED 
HYPROMELLOSES 
SODIUM BENZOATE 
STEARIC ACID 
TITANIUM DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C RED NO. 40 
SILICON DIOXIDE 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeTCL097
Contains    
Packaging
#Item CodePackage Description
1NDC:57896-303-01100 TABLET, FILM COATED in 1 BOTTLE
2NDC:57896-303-101000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/01/2014
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)
Establishment
NameAddressID/FEIOperations
Geri-Care Pharmaceuticals, Corp611196254repack(57896-303)

 
Geri-Care Pharmaceutical Corp

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Medically reviewed on Nov 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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