CALCIUM POLYCARBOPHIL 625 MG tablet

Calcium Polycarbophil 625 mg by

Drug Labeling and Warnings

Calcium Polycarbophil 625 mg by is a Otc medication manufactured, distributed, or labeled by Reliable 1 Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg

(equivalent to polycarbophil 500 mg)

Purpose

Bulk-Forming Laxative

Uses

• relieves occasional constipation
• 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 cuase 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.

DO NOT USE

Do not use longer than one week

ASK DOCTOR

Ask a doctor before use if you have

• abdominal pain, nausea, or vomiting
• noticed a sudden change in bowel habits that lasts over two weeks

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

STOP USE

Stop use and ask a doctor if

• you have rectal bleeding
• you fail to have a bowel movement after using this prodcut

These could be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Drug Facts continued on back of label

Directions

• take caplets with at least 8 ounces (a full glass) of water or other fluid. Taking this prodcut without enough liquid may cause choking. See choking warning.
• take dose up to 4 times daily
• do not take more than 8 caplets in 24 hours
• adults & children 12 years and over: 2 caplets
• children under 12 years: ask a doctor

Other information

• each caplet contains: calcium 140 mg
• store at 15°-30°C (59°-86°F)
• do not refrigerate
• protect from humidity

INACTIVE INGREDIENT

Inactive ingredients carob powder, croscarmellose sodium, HPMC, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide

QUESTIONS

Questions or comments? call 516-341-0666,

8:30 am - 4:30 pm ET, Monday-Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark FIBERCON®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliablel1labs.com

PRINCIPAL DISPLAY PANEL

NDC: 69618-030-06

Calcium Polycarbophil 625mg

Bulk-Forming Laxative

90 Caplets

*Compare to Active Ingredient in FIBERCON®

INGREDIENTS AND APPEARANCE

CALCIUM POLYCARBOPHIL 625 MG 
calcium polycarbophil 625 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-030
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CAROB (UNII: 5MG5Z946UO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	19mm
Flavor		Imprint Code	AP;067
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-030-06	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015
2	NDC: 69618-030-09	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015
3	NDC: 69618-030-50	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/01/2015

Labeler - Reliable 1 Laboratories LLC (079718111)