FDA.reportPublic FDA data

Premier Value Fiber Therapy

Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:31:24

Label at a glance#

ProductPremier Value Fiber Therapy
Active ingredientMETHYLCELLULOSE (4000 MPA.S)
Label structure7 sections

Indications and uses

▪ relieves occasional constipation (irregularity) ▪ generally produces a bowel movement in 12 -72 hours. 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 imme...

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Methylcellulose 500mg

Purpose

OTC - PURPOSE SECTION

Bulk-forming fiber laxative (a non-allergenic fiber)

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12 -72 hours.

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

  • Constipation lasts more than 7 days
  • you have rectal bleeding
  • These could be signs of a serious condition.
Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

  • each caplet contains: calcium 18 mg
  • store at room temperature
  • protect contents from humidity
  • keep tightly closed

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, calcium carbonate, crospovidone, FD&C Yellow no. 6, magnesium stearate, microcrystalline cellulose, polysorbate 80, silica.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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**
  • 100 CAPLETS

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.

Fiber Therapy Methylcellulose
Fiber Therapy Methylcellulose

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198750methylcellulose 500 MG Oral TabletPSN6
198750methylcellulose 500 MG Oral TabletSCD6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-122-10Premier Value Fiber Therapy100 in 1 BOTTLETABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-122PREMIER VALUE FIBER THERAPY (METHYLCELLULOSE) TABLET [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 1 package rows20241030_b875d5f8-02f3-4474-9fda-83091bc7de04.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-12268016-122-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLCELLULOSE (4000 MPA.S)MRJ667KA5EACTIB
ADIPIC ACID76A0JE0FKJIACT
CALCIUM CARBONATEH0G9379FGKIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value Fiber TherapyMETHYLCELLULOSEPHARMACY VALUE ALLIANCE, LLCb875d5f8-02f3-4474-9fda-83091bc7de042024-10-28WarningsExact identifier
ndc (package): 68016-122-10
ndc (product): 68016-122
ndc11 (package): 68016012210
spl id: 182df826-e61d-4057-990c-5fa5e0d1224e
spl set id: b875d5f8-02f3-4474-9fda-83091bc7de04

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.