GC 471-01

Drug Labeling and Warnings

Drug Details [pdf]

ORANGE FLAVOR GERI-MUCIL- psyllium powder, for solution 
Preferred Pharmaceuticals Inc.

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.

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GC 471-01

Active ingredient (in each rounded TABLESPOON)

Psyllium Powder, approximately 3.4 g

Purpose

Fiber laxative

Uses

• effective in treating occasional constipation and restoring and regularity.

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
  

Allergy alert

• This product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium.

Ask a doctor before use if you have

• have a sudden change in bowel habits that persist over a period of 2 weeks
• have abdominal pain, nausea, or vomiting

Stop use and ask a doctor if

• constipation lasts more than 7 days
• rectal bleeding occurs

These may be signs of a serious condition

Keep out of reach of children

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

Directions

Put one dose into an empty glass. 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 maycause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.

• adults & children 12 years & over:

  1 rounded TABLESPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.

• children under 12 years:

  consult a doctor.

Laxatives, including bulk fibers, may affect how well other
medicines work. If you are taking a prescription medicine by
mouth, take this product at least 2 hours before or 2 hours
after the prescribed medicine. As your body adjusts to
increased fiber intake, you may experience changes in bowel
habits or minor bloating. New Users: Start with 1 dose per
day; gradually increase to 3 doses per day as necessary.

Other information

• each teaspoonful contains: potassium 30 mg, sodium 5 mg
• Store a t room temperature.

Protect contents from humidity. Keep tightly closed.

Inactive Ingredients

Citric Acid, FD&C Yellow #6, Artificial Orange Flavor and Sucrose.

Product Label

ORANGE FLAVOR GERI-MUCIL 
psyllium powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-0800(NDC: 57896-471)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	3.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-0800-3	368 g in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2018	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/19/2018	10/01/2019

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc.CORP (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-0800)

Revised: 10/2019

Document Id: 91d4597c-39f7-45f6-9bd0-09bcab69939b

34390-5

Set id: 24513669-ba88-44ff-b745-604bf0d36d2c

Version: 2

Effective Time: 20191001