DOSAGE & ADMINISTRATION SECTION.


Directions. Dose once dailytake with to oz of milk, juice or infant formula to mask the bitter taste.adults and children 12 years and older5 to 20 mL (1 to teaspoonfuls)children to under 12 years of age5 to 10 mL (1 to teaspoonfuls)children to under years of age2.5 to mL (1/2 to teaspoonful)children under yearsask doctor. Dose once daily. take with to oz of milk, juice or infant formula to mask the bitter taste.

INACTIVE INGREDIENT SECTION.


Inactive ingredients. Citric acid, D&C Red No. 33, flavoring, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.

INDICATIONS & USAGE SECTION.


Uses. relieves occasional constipation (irregularity)generally produces bowel movement in 12 to 72 hours. relieves occasional constipation (irregularity). generally produces bowel movement in 12 to 72 hours.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredient (in each mL). Docusate sodium 50 mg.

OTC - ASK DOCTOR SECTION.


Ask doctor before use if you have. stomach painnauseavomitingnoticed sudden change in bowel habits that lasts over weeks. stomach pain. nausea. vomiting. noticed sudden change in bowel habits that lasts over weeks.

OTC - DO NOT USE SECTION.


Do not use. if you are presently taking mineral oil, unless told to do so by doctor. if you are presently taking mineral oil, unless told to do so by doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.


If pregnant or breast-feeding, ask health professional before use.

OTC - PURPOSE SECTION.


Purpose. Stool softener.

OTC - QUESTIONS SECTION.


Questions or comments. Call 1-800-845-8210.

OTC - STOP USE SECTION.


Stop use and ask doctor if. you have rectal bleeding or fail to have bowel movement after use of laxative. These could be signs of serious condition.you need to use stool softener laxative for more than weekrash occurs. you have rectal bleeding or fail to have bowel movement after use of laxative. These could be signs of serious condition.. you need to use stool softener laxative for more than week. rash occurs.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 10 mL Cup Tray Label. NDC 0121-0544-10Docusate Sodium Liquid (SUGAR FREE) 100 mg/10 mLSTOOL SOFTENER LAXATIVEUSUAL DOSAGE: See attached Drug FactsThis unit-dose package is not child-resistant.Store at 20 25C (68 77F) [See USP Controlled Room Temperature]. 10 10 mL Unit-Dose CupsPharmaceutical Associates, Inc.Greenville, SC 29605T0544101120 R11/20. PRINCIPAL DISPLAY PANEL 10 mL Cup Tray Label.

SPL UNCLASSIFIED SECTION.


Drug Facts.

STORAGE AND HANDLING SECTION.


Other information. Sodium content: 14 mg/ mLStore at controlled room temperature, 20 25C (68 77F)Protect from freezingProtect from lightPurple colored, cherry flavored liquid supplied in the following:NDC 0121-0544-16:16 fl oz (473 mL) bottleNDC 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.. Sodium content: 14 mg/ mL. Store at controlled room temperature, 20 25C (68 77F). Protect from freezing. Protect from light. Purple colored, cherry flavored liquid supplied in the following:.

WARNINGS SECTION.


Warnings. Do not use. if you are presently taking mineral oil, unless told to do so by doctor. if you are presently taking mineral oil, unless told to do so by doctor. Ask doctor before use if you have. stomach painnauseavomitingnoticed sudden change in bowel habits that lasts over weeks. stomach pain. nausea. vomiting. noticed sudden change in bowel habits that lasts over weeks. Stop use and ask doctor if. you have rectal bleeding or fail to have bowel movement after use of laxative. These could be signs of serious condition.you need to use stool softener laxative for more than weekrash occurs. you have rectal bleeding or fail to have bowel movement after use of laxative. These could be signs of serious condition.. you need to use stool softener laxative for more than week. rash occurs. If pregnant or breast-feeding, ask health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.