FIBER CAPLETS- calcium polycarbophil tablet

Fiber Caplets by

Drug Labeling and Warnings

Fiber Caplets by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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
• do not use if printed seal under cap is torn or missing
• 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

Product: 71335-1075

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

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

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

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

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE, UNSPECIFIED (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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-1075-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2019
2	NDC: 71335-1075-2	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2019
3	NDC: 71335-1075-3	120 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/01/2016

Labeler - Bryant Ranch Prepack (171714327)

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