Label: DOCUSATE SODIUM tablet, film coated
- NDC Code(s): 61919-498-60
- Packager: DIRECTRX
- This is a repackaged label.
- Source NDC Code(s): 16103-378
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated April 9, 2019
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- ACTIVE INGREDIENT
Do not use
laxative products for longer than 1 week unless directed by a doctor
if you are taking mineral oil, unless directed by a doctor
Ask a doctor before use if you have
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 the use of a laxative. These may indicate a serious condition.
If pregnant or breast feeding,
ask a healthcare professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center immediately.
INSTRUCTIONS FOR USE
take preferably at bedtime or as directed by a doctor
Adults and children 12 years and over
2 tablets once a day
4 tablets twice a day
Children 6 to under 12 years
1 tablet once a day
2 tablets twice a day
Children 2 to under 6 years
1/2 tablet once a day
1 tablet twice a day
Children under 2 years
ask a doctor
ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.
Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day
Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day
Children to2 to under 6 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day
Children under 2 years - Ask a doctor
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
docusate sodium tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-498(NDC:16103-378) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MAGNESIUM STEARATE (UNII: 70097M6I30) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM BENZOATE (UNII: OJ245FE5EU) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color orange (ORANGE COLOR) Score no score Shape ROUND (ROUND TABLET) Size 10mm Flavor Imprint Code PH32 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-498-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 11/05/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 11/05/2018 Labeler - DIRECTRX (079254320) Registrant - DIRECTRX (079254320) Establishment Name Address ID/FEI Business Operations DIRECTRX 079254320 repack(61919-498)