Label: PEDIA-LAX- docusate sodium liquid
- NDC Code(s): 0132-0106-24
- Packager: C.B. Fleet Company, Inc.
- 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 September 29, 2017
If you are a consumer or patient please visit this version.
- Active Ingredients
Drug interaction precaution: do not give this product to your child if your child is presently taking mineral oil unless directed by a doctor.
Ask a doctor before using any laxative if your child has
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
- if constipation continues after 1 week of use, contac your child's doctor
- Stop using this product and consult a doctor if your child has
- Keep out of reach of children
Use dosage chart for proper dosing. Doses may be taken as a single daily dose or in divided doses. Doses can be given in a glass of juice to prevent throat irritation and to help mask the naturally tart flavor of the active ingredient.
Age Starting Dose
Maximum dose per day (24 hours)
children 2 to 12 years 1 - 3 tablespoons 3 tablespoons children under 2 years ask a doctor
- Other information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
docusate sodium liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0106 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 15 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) XYLITOL (UNII: VCQ006KQ1E) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) SORBITOL (UNII: 506T60A25R) SODIUM CITRATE (UNII: 1Q73Q2JULR) POVIDONE (UNII: FZ989GH94E) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color pink Score Shape Size Flavor FRUIT PUNCH Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0106-24 118 mL in 1 CARTON; Type 0: Not a Combination Product 03/01/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/01/2008 Labeler - C.B. Fleet Company, Inc. (003119054) Establishment Name Address ID/FEI Business Operations C.B. Fleet Company, Inc. 003119054 manufacture(0132-0106)