FDA Label for Premier Value Fiber Therapy
View Indications, Usage & Precautions
Premier Value Fiber Therapy Product Label
The following document was submitted to the FDA by the labeler of this product Pharmacy Value Alliance, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Caplet)
Methylcellulose 500mg
Purpose
Bulk-forming fiber laxative (a non-allergenic fiber)
Uses
▪ relieves occasional 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?
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Premier Value®
NDC# 68016-122-10
*COMPARE TO THE ACTIVE INGREDIENTS CITRUCEL® CAPLETS
Fiber Therapy
Fiber Therapy for Regularity
Methylcellulose
• Gentle and clinically proven effective• Gives you additional fiber to help relieves occasional constipation• Fiber for irregularity that won’t cause excess gas**
If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.
*When Used As Directed.
**Based on Laboratory Testing.
Individual Results May Vary.
Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark CITRUCEL® Caplets.
* Please review the disclaimer below.