FDA Label for Fiber Laxative
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PACKAGE LABELING:
Fiber Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Magno-humphries, 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.
Active Ingredient (In Each Tablet)
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
- 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 tablets in a 24 hour period unless directed b y 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 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 tablets once a day up to 4 times a day
- children under 12 years of age: ask a doctor
Other Information
- each tablet contains: calcium 135 mg
- store at 20°-25°C (68°-77°F)
- protect contents from moisture
Inactive Ingredients
calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate.
Questions?
call toll-free 1-800-935-6737
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