GERI MUCIL- psyllium powder, for solution

Geri Mucil by

Drug Labeling and Warnings

Geri Mucil by is a Otc medication manufactured, distributed, or labeled by Gericare Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Front Panel:

NATURAL PSYLLIUM FIBER LAXATIVE & DIETARY SUPPLEMENT

• Gentle, Effective Relief From Constipation
• Daily Fiber Source
• No Chemical Stimulants

Back Panel:

LAXATIVE

Drug Facts

Active ingredient (in each rounded TEASPOON)

Psyllium Husk, approximately 3.4 g

Purpose

Bulk-forming 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,

  up to 3 times daily

• 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 teaspoon contains: potassium 30 mg, sodium 5 mg
• Store below 30°C (86°F)
• Protect contents from humidity. Keep tightly closed.

Inactive ingredient

sucrose

DIETARY FIBER SUPPLEMENT

Uses Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in Geri-Mucil, may reduce the risk of heart disease by lowering cholesterol. One adult does of Geri-Mucil has 2.4 grams of this soluble fiber. Consult a doctor if you are considering use of this product as part of a cholesterol-lowering program. 

Warnings

Read entire label, including warnings in Drug Facts.

Directions

Adults 12 yrs. & older; 1 rounded TEASPOON in 8 oz of liquid 3 times daily. Under 12 yrs.: Ask a doctor. See mixing directions in Drug Facts . NOTICE: Mix this product with at least 8 oz (a full glass) of liquid. Taking without enough liquid may cause choking. Do not take if you have difficulty swallowing. 

Supplement Facts
Serving Size 1 rounded teaspoon (7g); Servings per container 52
Amount Per Serving                      %DV**
Calories 25
Total Carbohydrates 7 g	2%
Dietary Fiber 3 g	12%
Soluble Fiber 2 g	*
Sugars 3 g	*
Iron 0.4 mg	2%
Sodium 5 mg	<1%
Potassium 30 mg	<1%
Psyllium Hydrophilic Mucilloid 3.4 g	†
**% Daily Value (DV) is based on a 2,000 calorie diet.
*Daily Value (DV) not established.

INGREDIENTS: Sucrose, Psyllium Husk

‡This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Metamucil®.

 DIST. BY:
GERI-CARE PHARMACEUTICALS CORP.
1650 63 rd STREET
BROOKLYN, NEW YORK 11204

04/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 

INGREDIENTS AND APPEARANCE

GERI MUCIL 
psyllium powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-461
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 7 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	Brown (Tanish-yellow)	Score	no score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-461-13	368 g in 1 Bottle

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Not Final	part334	06/22/2009

Labeler - Gericare Pharmaceuticals (611196254)