FDA Label for Premier Value Fiber Laxative
View Indications, Usage & Precautions
Premier Value Fiber Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium. 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 )
Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil
Purpose
Bulk-forming laxative
Uses
• relieves occasional constipation to help restore and maintain regularity• this product generally produces bowel movement in 12 to 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 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.
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 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
Other Information
• each caplet contains: calcium 125 mg• do not use if printed seal under cap is torn or missing• store at 20-25°C (68-77°F)• protect contents from moisture
Inactive Ingredients
calcium carbonate, caramel, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate
Principal Display Panel
NDC 68016-259-00
Premier Value
Fiber Caplets
FIBER LAXATIVE
Calcium Polycarbophil 625 mg
• Relieves constipation• Restores regularity• Daily source of fiber
COMPARE TO FIBERCON® ACTIVE INGREDIENT
90 CAPLETS
This product is not manufactured or distributed by Pfizer Consumer Healthcare, the distributor of FIBERCON®
Distributed by:
Chain Drug Consortium LLC.
3301 N.W. Boca Raton Blvd.
Suite 101, Boca Raton FL 33431
Fiber Laxative Label
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