HEALTH MART FIBER CAPLETS- methylcellulose tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 CPS) - UNII:MRJ667KA5E)
Available from:
Strategic Sourcing Services LLC
INN (International Name):
METHYLCELLULOSE - UNII:MRJ667KA5E)
Composition:
METHYLCELLULOSE (4000 CPS) 500 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Bulk-forming laxative - relieves occasional constipation to help restore and maintain regularity  - generally produces a bowel movement in 12-72 hours 
Authorization status:
OTC monograph not final
Authorization number:
62011-0134-1

HEALTH MART FIBER CAPLETS - methylcellulose tablet

Strategic Sourcing Services LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Health Mart Fiber Caplets

Active ingredient (in each caplet)

Methylcellulose 500 mg

Purpos e

Bulk-forming laxative

Us es

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 & 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 at below 25 C (77 F)

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

NDC 62011-0134-1

Health Mart

Compare to Citrucel

Caplets Active Ingredient*

Fiber Caplets

Methylcellulose 500 mg

Bulk-Forming Laxative

Helps Maintain & Restore Regularity

100 caplets

HEALTH MART FIBER CAPLETS

methylcellulose tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 20 11-0 134

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

METHYLCELLULO SE ( 4 0 0 0 CPS) (UNII: MRJ6 6 7KA5E) (METHYLCELLULOSE (40 0 0

CPS) - UNII:MRJ6 6 7KA5E)

METHYLCELLULOSE

(40 0 0 CPS)

50 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

Strategic Sourcing Services LLC

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

Product Characteristics

Color

o ra nge

S core

no sco re

S hap e

CAPSULE

S iz e

19 mm

Flavor

Imprint Code

G18 8

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 20 11-0 134-1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

10 /18 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt334

10 /18 /20 19

Labeler -

Strategic Sourcing Services LLC (116956644)

Registrant -

Guardian Drug Company (119210276)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Guardian Drug Co mpany

119 210 276

ma nufa c ture (6 20 11-0 134)

Revised: 10/2019

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