0339-Rugby

Drug Facts

Active ingredient (in each tablet) Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Purpose

Purpose Bulk-forming laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours

WARNINGS SECTION

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 Fiber-Lax two or more hours before or after other drugs. 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 tablets in a 24-hour period unless directed by a doctor

Stop use and ask a doctor if

• you fail to have a bowel movement after use or have rectal bleeding.

These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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 (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning

Other information

• each tablet contains: calcium 140 mg

• do not use if printed seal under cap is torn or missing • store in a dry place at 15° – 30°C (59° – 86°F).

• protect contents from moisture

Inactive ingredients

Caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, owner of the registered trademark FiberCon®

WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

Distributed by: Rugby Laboratories

Indianapolis, IN 46268 www.majorpharmaceuticals.com (800) 616-2471

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby

NDC 0536-4306-05

Comapare to Active ingredient in FiberCon*

Fiber-Lax

Calcium Polycarbophil 625 mg

Bulk-Forming Laxative

Safe and Effective Relief of Occasional Constipation

Promotes Regularity

500 Tablets