Active Ingredient (In Each Caplet)
Methylcellulose (a non-allergenic fiber) 500mg
Quality Choice Tablet
FDA Label NDC 83324-228
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Quality Choice (NDC 83324-228). 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 caplet), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Bulk-forming fiber laxative
Uses
▪ relieves constipation (irregularity)
▪ generally produces a bowel movement in 12 -72 hours.
Warnings
Choking: 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 A Doctor Before Use If You Have
▪ a sudden change in bowel habits that persists over a period of two weeks▪ abdominal pain, nausea or vomiting
Stop Use And Ask A Doctor If
▪ Constipation lasts more than 7 days▪ you have rectal bleeding.These could be signs of a serious condition.
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
Take this product (child or adult dose) 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.
Age | Dose | Maximum Dose |
adults & children 12 years of age and over | start with 2 caplets. Increase as needed up to 6 times per day. | Do not exceed 12 caplets per day |
Children 6-11 years of age | Start with 1 caplet. Increase as needed up to 6 times per day | Do not exceed 6 caplets per day |
children under 6 years of age | Consult a physician | Consult a physician |
Other Information
▪ each caplet contains: calcium 18 mg▪ store at room temperature▪ protect contents from humidity▪ keep tightly closed
Safety sealed: Do not use if printed seal under cap is torn or missing.
Inactive Ingredients
adipic acid, calcium carbonate, crospovidone, FD&C yellow no. 6, magnesium stearate, microcrystalline cellulose, polysorbate 80, silica.
Do not use if printed seal under cap is torn or missing.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
QUALITY CHOICE®
NDC# 83324-228-01
Compare to Citrucel® Caplets Active Ingredients*
Fiber Therapy
Methylcellulose
- Gentle and clinically proven effective†
- Gives you additional fiber to help relieve occasional constipation
- Fiber for irregularity that won’t cause excess gas††
100% QC SATISFACTION GURANTEED
Distributed by CDMA, Inc. ©
Novi, MI 48375
Questions: 800-935-2362
*This product is not manufactured or distributed by GlaxoSmithKline, the distributor of CITRUCEL® Caplets.
Qc(cdma) Fiber Therapy For Regularity 100 Caplets (122100pvlr Ol)
* Please review the disclaimer below.
