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NDC 49348-0541-10 Sunmark fiber laxative 500 mg/1 Details

Sunmark fiber laxative 500 mg/1

Sunmark fiber laxative is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is METHYLCELLULOSE (4000 CPS).

Product Information

NDC	49348-0541
Product ID	49348-541_85aff42b-4bd8-481b-ae16-6d968c386502
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	Sunmark fiber laxative
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	Strategic Sourcing Services LLC
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 49348-0541-10 (49348054110)

Pricing Information
NDC Package Code	49348-541-10
Billing NDC	49348054110
Package	100 TABLET in 1 BOTTLE (49348-541-10)
Marketing Start Date	2019-09-26
NDC Exclude Flag	N
Price Per Unit	0.066
Pricing Unit	EA
Effective Date	2023-08-23
NDC Description	SM FIBER LAXATIVE 500 MG CPLT
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 6b6d3d76-a5e6-42ad-a79e-bf5861a8446b Details

Active ingredient (in each caplet)

Methylcellulose 500 mg

Purpose

Bulk-forming laxative

Uses

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 a 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 and 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 6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulphate

Principal Display Panel

sunmark

COMPARE TO CITRUCEL® CAPLETS ACTIVE INGREDIENT*

fiber laxative

Bulk-Forming Laxative

Daily source of 100% soluble fiber

METHYLCELLULOSE 500 mg

THE FIBER WITH NO EXCESS GAS

100 CAPLETS

INGREDIENTS AND APPEARANCE

SUNMARK FIBER LAXATIVE

methylcellulose tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-541
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: 2S7830E561)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE (Caplet)	Size	19mm
Flavor		Imprint Code	G188
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49348-541-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/26/2019

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - Guardian Drug Company (119210276)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	manufacture(49348-541)

Revised: 1/2022

Document Id: 85aff42b-4bd8-481b-ae16-6d968c386502

Set id: 6b6d3d76-a5e6-42ad-a79e-bf5861a8446b

Version: 6

Effective Time: 20220106