Fiber Caplets (Calcium Polycarbophil) Tablet [Mckesson] -

FIBER CAPLETS (CALCIUM POLYCARBOPHIL) TABLET [MCKESSON]
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NDC	49348-190-13
Set ID	af62cc92-7803-4d4d-bcb8-2538e6f8848c
Category	HUMAN OTC DRUG LABEL
Packager	Strategic Sourcing Services LLC
Generic Name
Product Class
Product Number
Application Number	PART334

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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
PDP

sunmark

NDC 49348-190-13

*COMPARE TO FIBERCON CAPLETS

fiber caplets

Calcium Polycarbophil 625 mg

Relieves occasional constipation

Bulk forming laxative

90 Caplets

INGREDIENTS AND APPEARANCE

FIBER CAPLETS
calcium polycarbophil tablet

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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARAMEL (UNII: T9D99G2B1R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49348-190-13	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2019

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

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - Guardian Drug Company (119210276)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	manufacture(49348-190)

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