Registrants (1)
791119022
Manufacturing Establishments (1)
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
791119022
Products (1)
FIBER THERAPY
68788-7995
334
OTC Monograph Drug (C200263)
ORAL
May 12, 2025
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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)
INDICATIONS & USAGE SECTION
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
DOSAGE & ADMINISTRATION SECTION
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 |
WARNINGS SECTION
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 19g adult dose/ rounded tablespoon)
Methylcellulose 2g (a non-allergenic fiber)
OTC - PURPOSE SECTION
Purpose
Bulk-forming fiber laxative
OTC - QUESTIONS SECTION
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
Relabeled By: Preferred Pharmaceuticals Inc.
Livonia, MI 48152, USA
Relabeled By: Preferred Pharmaceuticals Inc.
DIRECTIONS FOR USE
1. Fill glass with at least 8 ounces of cold water.
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.
SPL UNCLASSIFIED SECTION
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 INGREDIENT SECTION
Inactive ingredients
citric acid, FD&C yellow 6 aluminum lake, maltodextrin, flavor (natural and artificial), potassium citrate, silica, sucrose,