HEMORRHOIDAL- cocoa butter, phenylephrine hydrochloride suppository

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Tilgængelig fra:

GRAXCELL PHARMACEUTICAL, LLC

Indgivelsesvej:

RECTAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

Protectant Vasoconstructor - temporarily shrinks hemorrhoidal tissues - gives temporary relief to the itching, burning and discomfort associated with hemorrhoids - aids in protecting irritated anorectal areas

Autorisation status:

OTC monograph final

Produktets egenskaber

HEMORRHOIDAL- COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY
GRAXCELL PHARMACEUTICAL, LLC
_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._
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HEMORRHOIDAL SUPPOSITORIES, 70795-1021
ACTIVE INGREDIENTS (PER SUPPOSITORY)
Cocoa butter 88.44 %
Phenylephrine hydrochloride 0.25 %
PURPOSE
Protectant
Vasoconstructor
USES
temporarily shrinks hemorrhoidal tissues
gives temporary relief to the itching, burning and discomfort
associated with
hemorrhoids
aids in protecting irritated anorectal areas
WARNINGS
FOR RECTAL USE ONLY
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
presently taking a prescription drug for high blood pressure or
depression
ASK A DOCTOR BEFORE USE IF YOU HAVE
heart disease
thyroid disease
high blood pressure
diabetes
difficulty in urination due to enlargement of the prostate gland
WHEN USING THIS PRODUCT
do not exceed the recommended daily dosage unless directed by a doctor
in case of bleeding or if condition worsens or does not improve within
7 days, consult
a doctor promptly
IF PREGNANT OR BREAST-FEEDING
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS ADULTS
detach one suppository from the strip. Remove the wrapper before
inserting into the
rectum.
insert one suppository into the rectum up to 4 times daily, especially
at night, in the
morning or after each bowel movement. Children under 12 years of age:
consult
doctor
OTHER INFORMATION
Store at room temperature or in a cool place but not over 80° F
INACTIVE INGREDIENTS
methylparaben, propylparaben, starch
HEMORRHOIDAL
cocoa butter, phenylephrine hydrochloride suppository
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70795-1021
ROUTE OF ADMINISTRATION
RECTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
COCOA BUTTER (