Label: PREMIER VALUE FIBER LAXATIVE- calcium polycarbophil tablet, film coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 68016-259-00 - Packager: Chain Drug Consortium
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 12, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet )
- Purpose
- Uses
-
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
-
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 dose
- 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
- Inactive ingredients
-
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
-
INGREDIENTS AND APPEARANCE
PREMIER VALUE FIBER LAXATIVE
calcium polycarbophil tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-259 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W) CALCIUM POLYCARBOPHIL 625 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CARAMEL (UNII: T9D99G2B1R) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 800 (UNII: UH6KR4953D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color BROWN (light) Score 2 pieces Shape CAPSULE (caplet) Size 19mm Flavor Imprint Code RP120 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-259-00 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/28/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/28/2015 Labeler - Chain Drug Consortium (101668460)
