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NDC 24385-0466-78 GNP Fiber Therapy 500 mg/1 Details

GNP Fiber Therapy 500 mg/1

GNP Fiber Therapy is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Amerisource Bergen. The primary component is METHYLCELLULOSE (4000 CPS).

Product Information

NDC	24385-0466
Product ID	24385-466_61c0e797-cc6e-414d-9205-1eb941118b4d
Associated GPIs	46300010000330
GCN Sequence Number	003053
GCN Sequence Number Description	methylcellulose TABLET 500 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09522
HICL Sequence Number	001341
HICL Sequence Number Description	METHYLCELLULOSE
Brand/Generic	Generic
Proprietary Name	GNP Fiber Therapy
Proprietary Name Suffix	n/a
Non-Proprietary Name	Methylcellulose
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	METHYLCELLULOSE (4000 CPS)
Labeler Name	Amerisource Bergen
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 24385-0466-78 (24385046678)

Pricing Information
NDC Package Code	24385-466-78
Billing NDC	24385046678
Package	1 BOTTLE in 1 CARTON (24385-466-78) / 100 TABLET in 1 BOTTLE
Marketing Start Date	2011-09-09
NDC Exclude Flag	N
Price Per Unit	0.066
Pricing Unit	EA
Effective Date	2023-08-23
NDC Description	FIBER THERAPY 500 MG CAPLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 9174cfdc-2145-4012-9490-953c47485fb5 Details

Active ingredient (in each caplet)

Methylcellulose 500 mg

Purpose

Bulk-forming laxative

Uses

helps restore and maintain regularity and relieves constipation (irregularity)
in the treatment of constipation associated with other bowel disorders when recommended by a doctor

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

abdominal pain, nausea or vomiting
a sudden change in bowel habits that persists over a period of 2 weeks
sensitivity to any of the ingredients

When using this product

do not exceed recommended maximum dose unless directed by a doctor
do not use laxative products for a period longer than one week unless directed by a doctor

Stop use and ask a doctor if

rectal bleeding occurs
you fail to have a bowel movement after use

Keep out of reach of children

In case of overdose, get medical help or contact a poison control center right away.

Directions

This product generally produces effect in 12-72 hours

take this product (child or adult) dose with atleast 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 and children over 12 years	2 caplets	up to 6 times daily
children (6 to 12 years)	1 caplet	up to 6 times daily
children under 6 years	ask a doctor	ask a doctor

Other information

each caplet contains: sodium 10 mg
store at room temperature 15o-30oC (59o-86oF)
protect contents from moisture
keep tightly closed
tamper evident: Do not use if printed seal under cap is torn or missing

Inactive ingredients

citric acid, colloidal silicon dioxide, crospovidone, FD&C yellow 6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulphate

Principal Display Panel

Good Neighbor Pharmacy

compare to Citrucel caplets active ingredient

fiber therapy

Methylcellulose Fiber Laxativebulk-forming laxative

easy to take with you

gentle fiber for regularity

daily source of 100% soluble fiber

100 caplets

INGREDIENTS AND APPEARANCE

GNP FIBER THERAPY

methylcellulose tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24385-466
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 CPS) - UNII:MRJ667KA5E)	METHYLCELLULOSE (4000 CPS)	500 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 68401960MK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	G188
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:24385-466-78	1 in 1 CARTON	09/09/2011
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/09/2011

Labeler - Amerisource Bergen (007914906)

Registrant - Guardian Drug Company (119210276)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	manufacture(24385-466)

Revised: 4/2016

Document Id: 61c0e797-cc6e-414d-9205-1eb941118b4d

Set id: 9174cfdc-2145-4012-9490-953c47485fb5

Version: 1

Effective Time: 20160415