FDA Label for Drx Choice Fiber Therapy
View Indications, Usage & Precautions
Drx Choice Fiber Therapy Product Label
The following document was submitted to the FDA by the labeler of this product Raritan Pharmaceuticals 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 Rounded Tablespoon)
Methylcellulose (a non-allergenic fiber) 2g
Purpose
Bulk-forming fiber laxative
Uses
▪ relieves occasional constipation (irregularity)▪ generally produces a bowel movement in 12-72 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
▪ a sudden change in bowel habits that persists for two weeks▪ abdominal pain, nausea or vomiting
Stop Use And Ask A Doctor If
▪ constipation lasts more than 7 days▪ you 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 right away at 1-800-222-1222.
Directions
• MIX THIS PRODUCT (CHILD OR ADULT DOSE) 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• use product at the first sign of constipation or irregularity• put one dose in a full glass of cold water• stir briskly and drink promptly• drinking another glass of water is helpful
Age | Dose |
adults & children 12 years of age and over | start with 1 rounded tablespoon. Increase as needed, 1 rounded tablespoon at a time, up to 3 times per day. |
children 6 - 11 years of age | start with 2 level teaspoons. Increase as needed, 2 level teaspoons at a time, up to 3 times per day. |
children under 6 years of age | consult a physician |
Other Information
• each rounded tablespoon contains: calcium 85mg and potassium 125mg• each rounded tablespoon contributes 27 calories from maltodextrin• store at room temperature• protect contents from humidity• keep tightly closed
Inactive Ingredients
Anhydrous citric acid, FD&C yellow #6 lake, flavor, maltodextrin, potassium citrate, silica, sucralose, tricalcium phosphate,
Questions Or Comments?
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DRx Choice®
Compare to the Active Ingredient in Citrucel® Powder*
NDC 68163-517-16
Sugar free
Soluble fiber therapy
Methylcellulose Fiber Therapy for Irregularity
• Gentle and clinically proven effective**• Gives you additional fiber to help relieve occasional constipation1. Fill glass with at least 8 oz. of cold water.2. Measure rounded tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly.
Fiber for irregularity that won’t cause excess gas***
Orange Flavor
Naturally & Artificially Flavored
NET WT 16.9 OZ (479g)
Directions for use:
**When Used As Directed.
***Based On Laboratory Testing. Individual Results may Vary
TAMPER EVIDENT: DO NOT USE PRINTED INNER SEAL IS BROKEN OR MISSING |
GLUTEN FREE
*This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Citrucel® Powder.
Manufactured By:
Raritan Pharmaceuticals
8 Joana Court,
East Brunswick, NJ 08816
* Please review the disclaimer below.