FIBER LAXATIVE- calcium polycarbophil tablet

FIBER LAXATIVE by

Drug Labeling and Warnings

FIBER LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Magno-Humphries, Inc.. 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 to help restore and maintain regularity
• 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
• 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 rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. 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 (1-800-222-1222) right away.

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, 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 of age and over: 2 caplets once a day up to 4 times a day
• children under 12 years of age: ask a doctor

Other information

• each caplet contains: calcium 125 mg
• store at 20°-25°C (68°-77°F)
• protect contents from moisture

Inactive ingredients

calcium carbonate, caramel color, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose,
polyethylene glycol, silicon dioxide, sodium lauryl sulfate.

Questions?

call toll-free 1-800-935-6737

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIBER LAXATIVE 
calcium polycarbophil tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54257-479
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)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CARAMEL (UNII: T9D99G2B1R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	white (Off-White)	Score	no score
Shape	OVAL (Caplet)	Size	18mm
Flavor		Imprint Code	RP120
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54257-479-07	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	07/25/2022

Labeler - Magno-Humphries, Inc. (063251433)