FIBER THERAPY ORANGE FLAVOR- psyllium dietary fiber supplement granule, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)

Available from:

Rij Pharmaceutical Corporation

INN (International Name):

PSYLLIUM HUSK

Composition:

PSYLLIUM HUSK 3.4 g in 100 g

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Fiber laxative / Dietary Fiber Supplement Fiber laxative - effective in treating occasional constipation and restoring and maintaining regularity. Generally produces bowel movement in 12-72 hours - encouragement for normal elimination naturally, without chemical stimulants Dietary FIber Supplement - Diets low in saturated fat and cholesterol that includes 12 gms of soluble fiber per day from psyllium husk, as in this product, may reduce the risk of heart disease by lowering cholesterol. One Adult dose of this product has 2.4 gms of this soluble fiber.

Authorization status:

OTC monograph not final

Summary of Product characteristics

FIBER THERAPY ORANGE FLAVOR - PSYLLIUM DIETARY FIBER SUPPLEMENT
GRANULE, FOR SOLUTION
RIJ PHARMACEUTICAL CORPORATION
_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._
----------
DRUG FACTS
ACTIVE INGREDIENTS (IN EACH DOSE)
Psyllium Hydrophilic Mucilloid 3.4 gms (approximately)
PURPOS E
Fiber laxative / Dietary Fiber Supplement
US ES
FIBER LAXATIVE
effective in treating occasional constipation and restoring and
maintaining regularity. Generally
produces bowel movement in 12-72 hours
encouragement for normal elimination naturally, without chemical
stimulants
DIETARY FIBER SUPPLEMENT
Diets low in saturated fat and cholesterol that includes 12 gms of
soluble fiber per day from
psyllium husk, as in this product, may reduce the risk of heart
disease by lowering cholesterol. One
Adult dose of this product has 2.4 gms of this soluble fiber.
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
Inhaled or ingested psyllium powder may cause allergic reaction in
people sensitive to psyllium
DO NOT USE
laxative products when abdominal pain, nausea or vomitting are present
unless directed by a doctor
this product if you have difficulty in swallowing or have any throat
problem.
ASK A DOCTOR BEFORE USE IF
LAXATIVE
you have a sudden change in bowel habits that persists over a period
of 2 weeks
DIETARY FIBER THERAPY
you are considering use of this product as part of
cholesterol-lowering program.
WHEN USING THIS PRODUCT
do not use more than 7 days unless directed by a doctor
STOP USE AND ASK A DOCTOR IF
you experince rectal bleeding
you faile to have bowel movement
constipation