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. artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, 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 16 fl oz (473 mL). NDC 0121-0935-16Docusate Sodium Liquid50 mg/5 mLSTOOL SOFTENER LAXATIVEAlcohol Free/Sugar Free16 fl oz (473 mL)Pharmaceutical Associates, Inc.Greenville, SC 29605X0935160721 R07/21. PRINCIPAL DISPLAY PANEL 16 fl oz (473 mL).

SPL UNCLASSIFIED SECTION.


Drug Facts.

STORAGE AND HANDLING SECTION.


Other information. Sodium content: 14 mg/ mL Store at controlled room temperature, 20 to 25C (68 to 77F) Protect from freezing Protect from light Clear pink to purple-pink colored, cherry flavored liquid supplied in the following: NDC 0121-0935-16: 16 fl oz (473 mL) bottle NDC 0121-0935-05: mL unit dose cup, in tray of ten cups. NDC 0121-1870-10: 10 mL unit dose cup, in tray of ten cups. o Sodium content: 14 mg/ mL Store at controlled room temperature, 20 to 25C (68 to 77F) Protect from freezing Protect from light Clear pink to purple-pink 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.