Silace
FDA Label NDC 54868-6311

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Silace (NDC 54868-6311). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Ask Doctor

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Storage And Handling

→ Inactive Ingredient

→ Otc - Questions

→ Other

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredient: Docusate sodium 60 mg (in each 15 mL (1 tablespoonful))

Otc - Purpose

Purpose: Stool Softener

Indications & Usage

Uses

for gentle, reliable relief from occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

laxative products for longer than 1 week unless told to do so by a doctor
Do not use if you are presently taking mineral oil unless told to do by a doctor

Otc - Ask Doctor

Ask a doctor before use if you have

stomach pain

nausea

vomiting

noticed a sudden change in bowel habits that last over two weeks

Otc - Stop Use

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding,

ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions

take as directed by a doctor

doses must be given in a 6-8 oz glass of milk or fruit juice, to prevent throat irritation

dose may be taken as a single daily dose or in divided doses

dosage should be adjusted to individual response

Adults and children 12 years of age and older	1 to 6 tablespoonfuls, or as directed by a doctor
Children 6 to under 12 years of age	1 to 2 1/2 tablespoonfuls, or as directed by a doctor
Children under 6 years	Ask a doctor

Storage And Handling

Other information

store at room temperature 20°-25°C (68°-77°F)

protect from freezing and excessive heat

do not use if tamper-evident safety seal around cap is broken or missing

dispense in tight, light-resistant container with a child-resistant closure

Inactive Ingredient

Inactive ingredients:

alcohol not more than 1%, citric acid, D&C red no. 33, FD&C red no. 40, peppermint flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucrose.