Quality Choice Tablet, Film Coated
FDA Label NDC 83324-276

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Quality Choice (NDC 83324-276). 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 drug fats, otc - purpose, u ses, warnings, ask your doctor before use if you have, ask your 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

→ Drug Fats

→ Otc - Purpose

→ U Ses

→ Warnings

→ Ask Your Doctor Before Use If You Have

→ Ask Your Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Overdosage

→ Directions

→ Other Information

→ Inactive Ingredient

→ Questions Or Comments?

→ Principal Display Panel

Drug Fats

Active Ingredient (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Otc - Purpose

Purpose

Bulk-forming laxative

U Ses

relieves occasional constipation to help restore and maintain regularity
this product generally produces bowel movement in 12 to 72 hours

Warnings

Choking Warning:Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Ask Your Doctor Before Use If You Have

abdominal pain, nausea, or vomiting
a sudden change in bowel habits that persists over a period of 2 weeks

Ask Your Doctor Or Pharmacist Before Use If You Are

taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.

When Using This Product

do not use for more than 7 days unless directed by a doctor
do not take more than 8 caplets in a 24 hour period unless directed by a doctor

Stop Use And Ask A Doctor If

rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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

Directions

Take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. (See choking warning).
This product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.

age	Recommended	Daily maximum
adults & children 12 years of age and over	2 caplets once a day	up to 4 times a day
children under 12 years	consult a physician

Other Information

each caplet contains: calcium 125 mg
store at room temperature
protect contents from moisture

Inactive Ingredient

calcium carbonate, caramel, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate.