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NDC 36800-0465-27 Fiber Laxative 625 mg/1 Details

Fiber Laxative 625 mg/1

Fiber Laxative is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates, LLC. The primary component is CALCIUM POLYCARBOPHIL.

Product Information

NDC	36800-0465
Product ID	36800-465_6d8a1ba3-aece-43e5-98f5-b611a96e25e4
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	Fiber Laxative
Proprietary Name Suffix	n/a
Non-Proprietary Name	Calcium polycarbophil
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	625
Active Ingredient Units	mg/1
Substance Name	CALCIUM POLYCARBOPHIL
Labeler Name	Topco Associates, 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 36800-0465-27 (36800046527)

Pricing Information	N/A
NDC Package Code	36800-465-27
Billing NDC	36800046527
Package	90 TABLET in 1 BOTTLE (36800-465-27)
Marketing Start Date	2020-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0609468d-ee66-49af-be40-e51965b88f6f Details

ACTIVE INGREDIENT (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

PURPOSE

Bulk-forming laxative

USE(S)

relieves occasional constipation
this product generally produces bowel movement in 12 to 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
difficulty in swallowing
a sudden change in bowel habits that persists over a period of 2 weeks

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.

WHEN USING THIS PRODUCT

do not use for more than 7 days unless directed by a doctor
do not take more than 8 caplets in a 24 hour period unless directed by a doctor

STOP USE AND ASK DOCTOR IF

you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
you fail to have a bowel movement after use or have rectal bleeding.

These could be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

In case of over dose, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

take this product (child or adult dose) with a full glass or water (8oz.) or other fluid. Taking this product without enough liquid may cause chocking. See choking warning.
dosage will vary according to diet, exercise, previous laxative use or severity of constipation
continued use for 1 to 3 days is normally required to provide full benefit

adults and children 12 years and over	2 caplets, 1 to 4 times a day
children under 12 years	ask a doctor

OTHER INFORMATION

each caplet contains: calcium 135 mg
store at room temperature
protect contents from moisture

INACTIVE INGREDIENTS

calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate.

PRINCIPAL DISPLAY PANEL

NDC 36800-465-27

Topcare`

COMPARE TO FIBERCON ACTIVE INGREDIENT

Fiber Laxative

CALCIUM POLYCARBOPHIL 625 mg

BULK-FORMING LAXATIVE

Gentle Enough for Everyday Use
Just as Effective as Fiber Powders

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

90 CAPLETS

INGREDIENTS AND APPEARANCE

FIBER LAXATIVE

calcium polycarbophil tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-465
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W)	CALCIUM POLYCARBOPHIL	625 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARAMEL (UNII: T9D99G2B1R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	WHITE (Off white)	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	G147
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-465-27	90 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	08/01/2020

Labeler - Topco Associates, LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	MANUFACTURE(36800-465)

Revised: 11/2022

Document Id: 6d8a1ba3-aece-43e5-98f5-b611a96e25e4

Set id: 0609468d-ee66-49af-be40-e51965b88f6f

Version: 2

Effective Time: 20221122