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NDC 41163-0288-16 Soluble Fiber 500 mg/1 Details

Soluble Fiber 500 mg/1

Soluble Fiber is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Supervalu Inc.. The primary component is METHYLCELLULOSE (4000 CPS).

Product Information

NDC	41163-0288
Product ID	41163-288_6decd5ef-e8e1-44ae-8465-6266cf18e81e
Associated GPIs
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	Soluble Fiber
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	Supervalu 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 41163-0288-16 (41163028816)

Pricing Information	N/A
NDC Package Code	41163-288-16
Billing NDC	41163028816
Package	100 TABLET in 1 BOTTLE (41163-288-16)
Marketing Start Date	2018-08-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6decd5ef-e8e1-44ae-8465-6266cf18e81e 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 41163-288-16

Compare to Citrucel Caplets active ingredient*

EQUALINE

soluble fiber caplets

methylcellulose 500 mg

bulk forming laxative

gently relieves constipation

100 Caplets

INGREDIENTS AND APPEARANCE

SOLUBLE FIBER

methylcellulose tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-288
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, UNSPECIFIED (UNII: 2S7830E561)
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:41163-288-16	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	08/24/2018

Labeler - Supervalu Inc. (006961411)

Revised: 8/2018

Document Id: 6decd5ef-e8e1-44ae-8465-6266cf18e81e

Set id: 6decd5ef-e8e1-44ae-8465-6266cf18e81e

Version: 1

Effective Time: 20180824