Label at a glance#

ProductORANGE FLAVOR GERI-MUCIL

Active ingredientPSYLLIUM HUSK

Label structure8 sections

Indications and uses

effective in treating occasional constipation and restoring and regularity.

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredient (in each rounded TABLESPOON)

OTC - ACTIVE INGREDIENT SECTION

Psyllium Powder, approximately 3.4 g

Purpose

OTC - PURPOSE SECTION

Fiber laxative

Uses

INDICATIONS & USAGE SECTION

effective in treating occasional constipation and restoring and regularity.

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

constipation lasts more than 7 days
rectal bleeding occurs

These may be signs of a serious condition

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

Protect contents from humidity. Keep tightly closed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

471

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57896-471-13	2021-04-14	C162847	48780-1	9d75b9d0-5173-f424-e053-dadaa90a57ce	GC 471-01
57896-471-13	2020-01-31	C162847	48780-1	9d75b9d0-5173-f424-e053-dadaa90a57ce	GC 471-01

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-471-13	GM - Gram	57896-471	93df1d88-8fa7-4838-a3fd-c66c255cf1f7	1	2018-06-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

ORANGE FLAVOR GERI-MUCIL
Psyllium
SUCROSE
PSYLLIUM HUSK
ANHYDROUS CITRIC ACID
FD&C YELLOW NO. 6
FOOD YELLOW 3 FREE ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57896-471	57896-471-13

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SUCROSE	C151H8M554	IACT
PSYLLIUM HUSK	0SHO53407G	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bff12bfe-3f57-7957-e053-2995a90a0e1f			6bdcb38d-d31e-b182-e053-2a91aa0af3ae	2021-04-14	Warnings	Exact identifier spl set id: 6bdcb38d-d31e-b182-e053-2a91aa0af3ae

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.