Label: CITRUCEL- methylcellulose powder, for solution
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NDC Code(s):
0135-0089-69,
0135-0089-71,
0135-0090-70,
0135-0090-74, view more0135-0090-75
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 15, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient CITRUCEL Orange
- Active ingredient CITRUCEL Sugar Free
- Purpose
- Uses
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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
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- a sudden change in bowel habits that persists for two weeks
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- abdominal pain, nausea or vomiting
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Directions
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- 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
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- use product at the first sign of constipation or irregularity
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- put one dose in a full glass of cold water
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- stir briskly and drink promptly
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- 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)
- Other information (Citrucel Sugar Free)
- Inactive ingredients (Citrucel Orange)
- Inactive ingredients (Citrucel Sugar Free)
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Questions or comments? (Citrucel Orange)
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
© 2020 GSK group of companies or its licensor.
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.
Questions or comments? (Citrucel Sugar Free)
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
©2020 GSK or licensor.
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.
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Principal Display Panel
NDC 0135-0089-69
Great Taste
CITRUCEL
METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY
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- Gentle and clinically proven effective*
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- Gives you additional fiber to help relieve occasional constipation
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- Fiber for irregularity that won’t cause excess gas**
orange FLAVOR
NET WT 16 OZ (454 GRAMS)
Great Tasting
CITRUCEL Orange
Citrucel offers these great benefits:
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- Gentle and clinically proven effective to help relieve occasional constipation*
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- Fiber that won't ferment to cause excess gas **
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- 100% Soluble, gluten-free, non-allergenic fiber
- *When Used As Directed.
- **Based On Laboratory Testing. Individual Results May Vary.
TAMPER EVIDENT PACKAGE
DO NOT USE IF FOIL SEAL IS MISSING OR BROKEN.
5E643
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Principal Display Panel
NDC 0135-0090-74
Great Taste
CITRUCEL
METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY
- •
- Gentle and clinically proven effective*
- •
- Gives you additional fiber to help relieve occasional constipation
- •
- Fiber for irregularity that won’t cause excess gas**
sugar free ORANGE FLAVOR
NET WT 32 OZ (907 GRAMS)
Great Tasting Orange Flavor
CITRUCEL Sugar Free
Citrucel offers these great benefits:
- •
- Gentle and clinically proven effective to help relieve occasional constipation*
- •
- Fiber that won't ferment to cause excess gas**
- •
- 100% Soluble, gluten-free, and non-allergenic fiber
- *When Used As Directed.
- **Based On Laboratory Testing. Individual Results May Vary.
TAMPER EVIDENT PACKAGE
DO NOT USE IF FOIL SEAL IS MISSING OR BROKEN.
5M245
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INGREDIENTS AND APPEARANCE
CITRUCEL
methylcellulose powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0089 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 MPA.S) - UNII:MRJ667KA5E) METHYLCELLULOSE (4000 MPA.S) 2 g in 19 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CITRATE (UNII: EE90ONI6FF) RIBOFLAVIN (UNII: TLM2976OFR) SUCROSE (UNII: C151H8M554) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) Product Characteristics Color ORANGE Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0089-69 454 g in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2010 2 NDC:0135-0089-71 850 g in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/16/2010 CITRUCEL
methylcellulose powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0090 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 MPA.S) - UNII:MRJ667KA5E) METHYLCELLULOSE (4000 MPA.S) 2 g in 10.2 g Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALIC ACID (UNII: 817L1N4CKP) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CITRATE (UNII: EE90ONI6FF) RIBOFLAVIN (UNII: TLM2976OFR) Product Characteristics Color ORANGE Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0090-70 479 g in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2010 2 NDC:0135-0090-74 907 g in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2010 3 NDC:0135-0090-75 1191 g in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/16/2010 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)