Label: DOCUSATE SODIUM liquid
- NDC Code(s): 0121-0544-10, 0121-0544-16, 0121-0544-25
- Packager: Pharmaceutical Associates, 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.
Drug Label Information
Updated January 19, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
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Directions
- Dose once daily
- take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste.
adults and children 12 years and older 5 to 20 mL (1 to 4 teaspoonfuls) children 6 to under 12 years of age 5 to 10 mL (1 to 2 teaspoonfuls) children 3 to under 6 years of age 2.5 to 5 mL (1/2 to 1 teaspoonful) children under 3 years ask a doctor -
Other information
- Sodium content: 14 mg/ 5 mL
- Store at controlled room temperature, 20° - 25°C (68° - 77°F)
- Protect from freezing
- Protect from light
- Purple colored, cherry flavored liquid supplied in the following:
NDC 0121-0544-16: 16 fl oz (473 mL) bottle NDC 0121-0544-10: 10 mL unit dose cup. Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each. NDC 0121-0544-25: 25 mL unit dose cup. Case contains 100 unit dose cups of 25 mL packaged in 10 trays of 10 unit dose cups each. - Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label
NDC 0121-0544-10
Docusate Sodium Liquid
(SUGAR FREE)100 mg/10 mL
STOOL SOFTENER LAXATIVE
USUAL DOSAGE: See attached Drug Facts
This unit-dose package is not child-resistant.
Store at 20° - 25°C (68° - 77°F)
[See USP Controlled Room Temperature].10 x 10 mL Unit-Dose Cups
Pharmaceutical Associates, Inc.
Greenville, SC 29605
T0544101120 R11/20
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-0544 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 SACCHARIN SODIUM (UNII: SB8ZUX40TY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color purple Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-0544-16 12 in 1 CASE 02/16/1983 1 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0121-0544-10 10 in 1 CASE 02/16/1983 2 10 in 1 TRAY 2 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 3 NDC:0121-0544-25 10 in 1 CASE 02/16/1983 3 10 in 1 TRAY 3 25 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 02/16/1983 Labeler - Pharmaceutical Associates, Inc. (044940096) Establishment Name Address ID/FEI Business Operations Pharmaceutical Associates, Inc. 097630693 manufacture(0121-0544)