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NDC 63868-0078-10 Quality Choice Fiber Therapy 500 mg/1 Details

Quality Choice Fiber Therapy 500 mg/1

Quality Choice Fiber Therapy is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association Inc.. The primary component is METHYLCELLULOSE (4000 MPA.S).

Product Information

NDC	63868-0078
Product ID	63868-078_4448e633-8341-44aa-8958-fcc87c617648
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Quality Choice 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 MPA.S)
Labeler Name	Chain Drug Marketing Association Inc.
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 63868-0078-10 (63868007810)

Pricing Information	N/A
NDC Package Code	63868-078-10
Billing NDC	63868007810
Package	100 TABLET in 1 BOTTLE (63868-078-10)
Marketing Start Date	2022-07-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4448e633-8341-44aa-8958-fcc87c617648 Details

ACTIVE INGREDIENT(in each caplet)

Methylcellulose 500 mg

PURPOSE

Bulk-forming laxative

USE(S)

relieves occasional constipation to help restore and maintain regularity
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

abdominal pain, nausea or vomiting
a sudden change in bowel habits that persists over a period of 2 weeks

WHEN USING THIS PRODUCT

do not use laxative products for a period longer than one week unless directed by a doctor.
do not use if you are on a low salt diet unless directed by a doctor.

STOP USE AND ASK DOCTOR IF

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

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

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 & children 12 years & over	2 caplets	up to 6 times daily
children 6 to 11 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 below 25oC (77oF)
protect contents from moisture
keep tightly closed

INACTIVE INGREDIENTS

citric acid, colloidal silicon dioxide, crospovidone, FD&C yellow no.6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulfate.

PRINCIPAL DISPLAY PANEL

NDC 63868-078-10

QC

QUALITY CHOICE

Fiber Therapy

Bulk Forming Laxative

Methylcellulose

Fiber Therapy for Regularity

Gentle & Gluten Free

100 Caplets

INGREDIENTS AND APPEARANCE

QUALITY CHOICE FIBER THERAPY

methylcellulose tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-078
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 MPA.S) - UNII:MRJ667KA5E)	METHYLCELLULOSE (4000 MPA.S)	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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	G188
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-078-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	07/28/2022

Labeler - Chain Drug Marketing Association Inc. (011920774)

Revised: 7/2022

Document Id: 4448e633-8341-44aa-8958-fcc87c617648

Set id: 4448e633-8341-44aa-8958-fcc87c617648

Version: 1

Effective Time: 20220729