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NDC 00224-1852-80 Konsyl Orange Flavor Psyllium Fiber - Smooth Texture 3.4 g/12g Details

Konsyl Orange Flavor Psyllium Fiber - Smooth Texture 3.4 g/12g

Konsyl Orange Flavor Psyllium Fiber - Smooth Texture is a ORAL GRANULE in the HUMAN OTC DRUG category. It is labeled and distributed by Konsyl Pharmaceuticals, Inc.. The primary component is PSYLLIUM HUSK.

MedlinePlus Drug Summary

Psyllium, a bulk-forming laxative, is used to treat constipation. It absorbs liquid in the intestines, swells, and forms a bulky stool, which is easy to pass. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 00224-1852-80
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Psyllium

Product Information

NDC	00224-1852
Product ID	0224-1852_d455865c-148b-1a49-e053-2a95a90af656
Associated GPIs	46300030103029 46300030102929
GCN Sequence Number	072014
GCN Sequence Number Description	psyllium husk (with sugar) POWD PACK 3.4 G ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	36077
HICL Sequence Number	035883
HICL Sequence Number Description	PSYLLIUM HUSK (WITH SUGAR)
Brand/Generic	Generic
Proprietary Name	Konsyl Orange Flavor Psyllium Fiber - Smooth Texture
Proprietary Name Suffix	n/a
Non-Proprietary Name	PSYLLIUM HUSK
Product Type	HUMAN OTC DRUG
Dosage Form	GRANULE
Route	ORAL
Active Ingredient Strength	3.4
Active Ingredient Units	g/12g
Substance Name	PSYLLIUM HUSK
Labeler Name	Konsyl Pharmaceuticals, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	n/a

Package

Package Images

NDC 00224-1852-80 (00224185280)

Pricing Information	N/A
NDC Package Code	0224-1852-80
Billing NDC	00224185280
Package	538 g in 1 CANISTER (0224-1852-80)
Marketing Start Date	2011-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d046e651-fcaf-4e83-a8b0-d5836b524c98 Details

KONSYL Orange Flavor Psyllium Fiber - Smooth Texture

Active Ingredient (in each tablespoon)

Psyllium Hydrophilic Mucilloid 3.4 g

Purpose

Laxative

Uses

For relief of occasional constipation and to induce regularity. This product generally produces bowel movement within 12-72 hours.

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.

Do not use

when abdominal pain, nausea or vomiting are present unless directed by a doctor
If constipation lasts more than seven days
if you have difficulty swallowing

Ask a doctor before use if you have

noticed a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

you experience rectal bleeding or fail to have a bowel movement, as 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.

Directions

Mix this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough fluid may cause choking. See choking warning.

adults and children 12 years and older	one teaspoon 1 to 3 times daily
children 6 to under 12 years of age	1/2 teaspoon 1 to 3 times daily
children under 6 years of age	consult a doctor.

Other Information

each tablespoon contains Potassium 25mg, Sodium 5mg
laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before or after taking other medicines
tamper-evident bottle mouth sealed for your protection
do not use if imprinted inner seal is broken or missing
do not discard Konsyl into any plumbing system
store below 86 degrees F (30 degrees C)
keep container tightly closed-protect from excessive moisture
can be taken before or after meals, mornings or evenings

Inactive Ingredients

Citric Acid, D&C Yellow No. 10, FD&C Yellow No. 6, Natural and Artificial Orange Flavor, Sugar

Questions or Comments?

1-800-356-6795 8:30 a.m. to 5 p.m. ET.

Representative Labeling

Package Labeling: 0224-1852-80

Package Labeling: 0224-1852-81

INGREDIENTS AND APPEARANCE

KONSYL ORANGE FLAVOR PSYLLIUM FIBER - SMOOTH TEXTURE

psyllium husk granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0224-1852
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	3.4 g in 12 g

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0224-1852-06	538 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011	04/01/2020
2	NDC:0224-1852-80	538 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011	05/01/2024
3	NDC:0224-1852-81	30 in 1 BOX	03/31/2011	08/01/2022
3		12 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC:0224-1852-13	30 in 1 BOX	03/31/2011	01/01/2020
4		12 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/31/2011	05/01/2024

Labeler - Konsyl Pharmaceuticals, Inc. (102463866)

Registrant - Konsyl Pharmaceuticals, Inc. (102463866)

Revised: 12/2021

Document Id: d455865c-148b-1a49-e053-2a95a90af656

Set id: d046e651-fcaf-4e83-a8b0-d5836b524c98

Version: 11

Effective Time: 20211229