GERI MUCIL- psyllium husks powder, for solution

Geri mucil by

Drug Labeling and Warnings

Geri mucil by is a Otc medication manufactured, distributed, or labeled by GERI-CARE PHARMACEUTICALS, CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

(in each rounded TEASPOON)

Psyllium Powder, approximately 3.4 g

Purpose

Fiber Laxative

Uses

• effective in treating occasional constipation and restoring 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

• a sudden change in bowel habits persisting for 2 weeks
• 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 overdose, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

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 may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.

• adults & children 12 years & over: 1 rounded TEASPOON 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 one dose per day; gradually increase to 3 doses per day as necessary.

OTHER SAFETY INFORMATION

Other information

• each teaspoonful contains: potassium 30 mg, sodium 5 mg
• Store at room temperature. Protect contents from humidity. Keep tightly closed.

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GERI MUCIL 
psyllium husks powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-491
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 5.8 g

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	orange (pale orange)	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-491-10	283 g in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/08/2011

Labeler - GERI-CARE PHARMACEUTICALS, CORP (611196254)

Registrant - GERI-CARE PHARMACEUTICALS, CORP (611196254)