Publix Laxative Tablet
FDA Label NDC 41415-114

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets, Inc for the product Publix Laxative (NDC 41415-114). 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 active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product,, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Tablet)

→ Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product,

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Active Ingredient (In Each Tablet)

Calcium Sennosides 25 mg

Purpose

Stimulant laxative

Uses

▪relieves occasional constipation (irregularity)
▪generally produces bowel movement in 6 to 12 hours

Do Not Use

laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Ask A Doctor Before Use If You Have

▪noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

When Using This Product,

do not use for a period longer than 1 week.

Stop Use And Ask A Doctor If

▪rectal bleeding or failure to have a bowel movement occurs after use of a laxative.

These may be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Directions

▪swallow tablet(s) with a glass of water
▪swallow tablet(s) whole; do not crush, break, or chew

adults and children 12 years and over	take 2 tablets once or twice daily with a glass of water
children 6 to under 12 years	take1 tablet once or twice daily with a glass of water
children under 6 years	ask a doctor

Other Information

▪each tablet contains: calcium 40 mg, magnesium 10 mg
▪store at room temperature

Inactive Ingredients

acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dehydrate, FD&C Blue No. 1, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium sterate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide.