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NDC 71335-1075-01 Fiber Caplets 625 mg/1 Details

Fiber Caplets 625 mg/1

Fiber Caplets is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is CALCIUM POLYCARBOPHIL.

Product Information

NDC	71335-1075
Product ID	71335-1075_3e0aedef-6bd5-4ee9-b1f4-16a84d396f93
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 Caplets
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	Bryant Ranch Prepack
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71335-1075-01 (71335107501)

Pricing Information	N/A
NDC Package Code	71335-1075-1
Billing NDC	71335107501
Package	30 TABLET in 1 BOTTLE (71335-1075-1)
Marketing Start Date	2022-02-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3e0aedef-6bd5-4ee9-b1f4-16a84d396f93 Details

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Purpose

Bulk-forming laxative

uses

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 a 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 the reach of children

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

Directions

take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
dosage will vary according to diet, excercise, previous laxative use or severity of constipation.
continued use for 1 or 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 135mg
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

HOW SUPPLIED

NDC: 71335-1075-1: 30 Tablets in a BOTTLE

NDC: 71335-1075-2: 60 Tablets in a BOTTLE

NDC: 71335-1075-3: 120 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Calcium Polycarbophil 625mg Tablet

INGREDIENTS AND APPEARANCE

FIBER CAPLETS

calcium polycarbophil tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-1075(NDC:49348-190)
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARAMEL (UNII: T9D99G2B1R)

Product Characteristics
Color	white	Score	no score
Shape	capsule	Size	19mm
Flavor		Imprint Code	G147
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-1075-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
2	NDC:71335-1075-2	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
3	NDC:71335-1075-3	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/18/2019

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-1075) , RELABEL(71335-1075)

Revised: 2/2022

Document Id: 3e0aedef-6bd5-4ee9-b1f4-16a84d396f93

Set id: 3e0aedef-6bd5-4ee9-b1f4-16a84d396f93

Version: 2

Effective Time: 20220214