Active Ingredient (In Each 19G Adult Dose/ Rounded Tablespoon)
Methylcellulose 2g (a non-allergenic fiber)
Fiber Therapy Powder, For Solution
FDA Label NDC 68788-7995
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals Inc. for the product Fiber Therapy (NDC 68788-7995). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 19g adult dose/ rounded tablespoon), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Bulk-forming fiber laxative
Uses
- relieves constipation (irregularity)
- helps to restore and maintain regularity
- for treating bowel disorders when recommended by a doctor
- generally provide effect 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
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits that persists over a period of 2 weeks
- sensitivity to any of the ingredients
Stop Use And Ask A Doctor If
- you have rectal bleeding
- you fail to have a bowl movement after use.
- 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.
When Using This Product
- do not exceed recommended maximum daily dose unless directed by a doctor
- do not use laxative products for a period longer than one week unless directed by a doctor
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 above 12 years of age and over | one rounded tablespoon. (19 g) in 8 ounces of water fluid up to 3 times daily at the first sign of constipation or irregularity |
children 6 - 12 years of age | half the adult dose in 8 ounces of water once daily. |
children under 6 years of age | ask a doctor |
Other Information
- each adult dose contains approximately
- 3 mg of sodium
- 105 mg potassium
- contributes 60 calories from sucrose and sorbitol
- store at room temperature
- protect contents from humidity
- keep tightly closed
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Inactive Ingredients
citric acid, FD&C yellow 6 aluminum lake, maltodextrin, flavor (natural and artificial), potassium citrate, silica, sucrose,
Questions Or Comments?
1-800-616-2471
*This product is not manufactured or distributed by GlaxoSmithKline the distributor of CITRUCEL®
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152, USA
Relabeled By: Preferred Pharmaceuticals Inc.
DIRECTIONS FOR USE
Image Of Pouring Water Into Glass (Fiber Therapy 1)
1. Fill glass with at least 8 ounces of cold water.
Image Of Stirring Water After Adding Citrucel (Fiber Therapy 2)
2. Add the adult or child dose listed in the directions. 3. Stir briskly until dissolved and drink promptly. Drinking an additional glass of water is helpful.
Principal Display Panel
NDC 68788-7995-4
Compare to the Active Ingredient in CITRUCEL®*
FIBER THERAPY
Methylcellulose
Easy to Mix No Gritty Texture
100% Soluble Fiber for Controlled Regularity
ORANGE FLAVOR
NET WT 16 OZ (454 GRAMS)
Fiber Therapy Orange Flavored (Fiber Therapy 3)
* Please review the disclaimer below.
