FDA Label for Citrucel
View Indications, Usage & Precautions
- ACTIVE INGREDIENT CITRUCEL® ORANGE
- ACTIVE INGREDIENT CITRUCEL® SUGAR FREE
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION (CITRUCEL® ORANGE)
- OTHER INFORMATION (CITRUCEL® SUGAR FREE)
- INACTIVE INGREDIENTS (CITRUCEL® ORANGE)
- INACTIVE INGREDIENTS (CITRUCEL® SUGAR FREE)
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Citrucel Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. 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 Citrucel® Orange
(in each heaping tablespoon)
Methylcellulose (a non-allergenic fiber) 2g
Active Ingredient Citrucel® Sugar Free
(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.
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
CITRUCEL® Orange
Age | Dose |
adults & children 12 years of age and over | start with 1 heaping tablespoon. Increase as needed, 1 heaping tablespoon at a time, up to 3 times per day. |
children 6 - 11 years of age | start with 2.5 level teaspoons. Increase as needed, 2.5 level teaspoons at a time, up to 3 times per day. |
children under 6 years of age | consult a physician |
CITRUCEL® Sugar Free
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 (Citrucel® Orange)
• each heaping tablespoon contains: calcium 80mg and potassium 110mg• each heaping tablespoon contributes 60 calories from sucrose and maltodextrin• store below 77°F (25°C)• protect contents from humidity• keep tightly closed
Other Information (Citrucel® Sugar Free)
• each rounded tablespoon contains: calcium 85mg and potassium 125mg• each rounded tablespoon contributes 24 calories from maltodextrin• store below 77°F (25°C)• protect contents from humidity• keep tightly closed• Phenylketonurics: CONTAINS PHENYLALANINE 52mg per adult dose
Inactive Ingredients (Citrucel® Orange)
citric acid, dibasic calcium phosphate, FD&C yellow #6 lake, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin, sucrose, titanium dioxide, tricalcium phosphate
Inactive Ingredients (Citrucel® Sugar Free)
aspartame, dibasic calcium phosphate, FD&C yellow #6 lake, malic acid, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin
Questions Or Comments?
call toll-free 1-800-897-6081
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
© 2012 The GSK group of companies or its licensor. All rights reserved.
CITRUCEL® Orange
DIRECTIONS FOR USE (NO SCOOP DOSING):
1. Fill glass with at least 8 oz. of cold water.
2. Measure heaping tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly.
CITRUCEL® Sugar Free
DIRECTIONS FOR USE (NO SCOOP DOSING):
1. 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.
Principal Display Panel
NDC 0135-0089-71
Great Taste
CITRUCEL®
METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY
• Gentle and clinically proven effective*• Gives you additional fiber to help relieve occasional constipation• The ONLY fiber for irregularity that won’t cause excess gas**• Gentle and clinically proven effective to help relieve occasional constipation*• The ONLY fiber that won't ferment to cause excess gas like other fiber products**• 100% Soluble, gluten-free, non-allergenic fiber• Gentle and clinically proven effective*• Gives you additional fiber to help relieve occasional constipation• The ONLY fiber for irregularity that won’t cause excess gas**• Gentle and clinically proven effective to help relieve occasional constipation*• The ONLY fiber that won't ferment to cause excess gas like other fiber products**• 100% Soluble, gluten-free, and non-allergenic
orange FLAVOR
NET WT 30 OZ (850 GRAMS)
Great Tasting
CITRUCEL® Orange
Citrucel is unique because it is:
TAMPER EVIDENT PACKAGE
BOTTLE SEALED WITH PRINTED FOIL UNDER CAP. DO NOT USE IF FOIL IS MISSING OR BROKEN.
105079XB
NDC 0135-0090-74
Great Taste
CITRUCEL®
METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY
sugar free ORANGE FLAVOR
NET WT 32 OZ (907 GRAMS)
Great Tasting Orange Flavor
CITRUCEL® Sugar Free
Citrucel is unique because it is:
TAMPER EVIDENT PACKAGE
BOTTLE SEALED WITH PRINTED FOIL UNDER CAP. DO NOT USE IF FOIL IS MISSING OR BROKEN.
105088XB
* Please review the disclaimer below.