Label: STOOL SOFTENER LIQUID- docusate sodium liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-0398-1, 17856-0398-2 - Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 46122-399
- 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.
Drug Label Information
Updated January 18, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL teaspoonful)
- Purpose
- Uses
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Warnings
Do not use for more than one week unless directed by a doctor
Ask a doctor before use if you
- have abdominal pain, nausea, or vomiting
- are taking mineral oil
- have noticed a sudden change in bowel habits that lasts more than 14 days
Stop use and ask a doctor if
- you have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition.
- a skin rash occurs
- you experience throat irritation
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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Directions
- follow dosing directions below or take as directed by doctor
- must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation
- may be taken as a single daily dose or in divided doses
- take maximum daily dose until first bowel movement, then reduce dose according to individual response
- shake well before using
Adults and children 12 years and over
1 to 4 teaspoonfuls (5 to 20 mL)
Children under 12 years of age
ask a doctor - Other information
- Inactive ingredients
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package label
NDC 17856-0398-1
Compare to Colace® Liquid active ingredient *
GOOD NEIGHBOR PHARMACY
STOOL
SOFTENER
LIQUID
Docusate Sodium
Relieves Constipation
250mg/25 mL50 cups per case
NDC 17856-0398-2
Compare to Colace® Liquid active ingredient *
GOOD NEIGHBOR PHARMACY
STOOL
SOFTENER
LIQUID
Docusate Sodium
Relieves Constipation
100mg/10 mL72 cups per case
-
INGREDIENTS AND APPEARANCE
STOOL SOFTENER LIQUID
docusate sodium liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-0398(NDC:46122-399) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) POLOXAMER 407 (UNII: TUF2IVW3M2) SUCROSE (UNII: C151H8M554) SORBITOL (UNII: 506T60A25R) Product Characteristics Color pink Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-0398-1 50 in 1 BOX, UNIT-DOSE 01/18/2021 1 25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:17856-0398-2 72 in 1 BOX, UNIT-DOSE 01/18/2021 2 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/01/2017 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 relabel(17856-0398) , repack(17856-0398)