drug facts

drug facts
SPL v22
SPL
SPL Set ID d27f6742-2dcc-451e-b803-6ffe183038ec
Route
oral
Published
Effective Date 2023-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
methylcellulose (4000 mpa.s) (500 mg)
Inactive Ingredients
crospovidone, unspecified anhydrous dibasic calcium phosphate fd&c yellow no. 6 magnesium stearate maltodextrin povidone, unspecified sodium lauryl sulfate

Identifiers & Packaging

Pill Appearance
Imprint: CIT Shape: freeform Color: orange Size: 19 mm Score: 1
Marketing Status
otc monograph drug active Since 2010-02-01

Purpose

Bulk-forming fiber laxative

Description

Methylcellulose (a non-allergenic fiber) 500mg


Medication Information

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.

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12- 72 hours
Purpose

Bulk-forming fiber laxative

Directions

Take 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.

Age

Dose

Maximum Dose

adults & children 12 years of age and over

start with 2 caplets. Increase as needed up to 6 times per day.

do not exceed 12 caplets per day

children 6 - 11 years of age

start with 1 caplet. Increase as needed up to 6 times per day.

do not exceed 6 caplets per day

children under 6 years of age

consult a physician

consult a physician

Other Information
  • each caplet contains: calcium 10mg
  • store below 77 oF (25 oC)
  • protect contents from humidity
  • keep tightly closed
Inactive Ingredients

crospovidone, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate

Description

Methylcellulose (a non-allergenic fiber) 500mg

Principal Display Panel

NDC 0135-0199-01

CITRUCEL

METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY

Easy Flip Top Cap

  • Gentle and clinically proven effective*
  • Gives you additional fiber to help relieve occasional constipation
  • Fiber for regularity that won’t cause excess gas**

180 Fiber caplets

105120XC

Questions Or Comments?

call toll-free 1-800-897-6081

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.

Active Ingredient (in Each Caplet)

Methylcellulose (a non-allergenic fiber) 500mg

Ask A Doctor Before Use If You Have
  • a sudden change in bowel habits that persists for two weeks
  • abdominal pain, nausea or vomiting
Additional Information Found On Label

TAMPER EVIDENT PACKAGE

BOTTLE SEALED WITH PRINTED FOIL UNDER CAP.

DO NOT USE IF FOIL IS MISSING OR BROKEN.

Distributed by:

GSKConsumer Healthcare

Warren, NJ 07059

*When Used As Directed.

**Based On Laboratory Testing.

Individual Results May Vary.

Trademarks are owned by or licensed to the GSK group of companies

©2018 GSK or its licensor.


Structured Label Content

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.

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12- 72 hours
Purpose

Bulk-forming fiber laxative

Directions

Take 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.

Age

Dose

Maximum Dose

adults & children 12 years of age and over

start with 2 caplets. Increase as needed up to 6 times per day.

do not exceed 12 caplets per day

children 6 - 11 years of age

start with 1 caplet. Increase as needed up to 6 times per day.

do not exceed 6 caplets per day

children under 6 years of age

consult a physician

consult a physician

Other Information (Other information)
  • each caplet contains: calcium 10mg
  • store below 77 oF (25 oC)
  • protect contents from humidity
  • keep tightly closed
Inactive Ingredients (Inactive ingredients)

crospovidone, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate

Principal Display Panel

NDC 0135-0199-01

CITRUCEL

METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY

Easy Flip Top Cap

  • Gentle and clinically proven effective*
  • Gives you additional fiber to help relieve occasional constipation
  • Fiber for regularity that won’t cause excess gas**

180 Fiber caplets

105120XC

Questions Or Comments? (Questions or comments?)

call toll-free 1-800-897-6081

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Methylcellulose (a non-allergenic fiber) 500mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a sudden change in bowel habits that persists for two weeks
  • abdominal pain, nausea or vomiting
Additional Information Found On Label (Additional information found on label)

TAMPER EVIDENT PACKAGE

BOTTLE SEALED WITH PRINTED FOIL UNDER CAP.

DO NOT USE IF FOIL IS MISSING OR BROKEN.

Distributed by:

GSKConsumer Healthcare

Warren, NJ 07059

*When Used As Directed.

**Based On Laboratory Testing.

Individual Results May Vary.

Trademarks are owned by or licensed to the GSK group of companies

©2018 GSK or its licensor.


Advanced Ingredient Data


Raw Label Data

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