FDA Label for Publix
View Indications, Usage & Precautions
- DRUG FATS
- OTC - PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK YOUR DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Publix Product Label
The following document was submitted to the FDA by the labeler of this product Publix Super Markets, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Fats
Active Ingredient (in each caplet)
Calcium polycarbophil 625 mg
equivalent to 500 mg polycarbophil
Otc - Purpose
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 Warning: 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 Your 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 tablets 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
▪ Take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. (See choking warning).▪ This product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.
Age | Recommended dose | Daily maximum |
adults & children 12 years of age and over | 2 caplets once a day | up to 4 times a day |
children under 12 years | consult a physician |
Other Information
• each caplet contains: calcium 125 mg• store at room temperature• protect contents from moisture
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Inactive Ingredient
calcium carbonate, caramel color, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC# 41415-021-90
*COMPARE TO THE ACTIVE INGREDIENTS FIBERCON® Caplets
Fiber Caplets
CALCIUM POLYCARBOPHIL 625 mg
BULK-FORMING FIBER LAXATIVE
• Gentle Relief of Constipation• Won’t Cause Gas or Bloating
90 CAPLETS
DISTRIBUTED BY: PUBLIX SUPAER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811
1-888-267-3037 publix.com
PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK
*This product is not manufactured or distributed by Pfizer Inc., owner of the registered trademark Fibercon® Caplets.
* Please review the disclaimer below.