PHENYLEPHRINE HYDROCHLORIDE- phenylephrine hydrochloride suppository 
Aditya Labs Inc

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

Drug Facts

Active Ingredients Purpose
Cocoa butter 85.5%...............................................Protectant
Phenylephrine hydrochloride 0.25%................Vasoconstructor

Uses

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

Directions

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 a doctor

Children under 12 years of age: consult a doctor

WARNINGS

For rectal use only
Ask a doctor or pharmacist before use if your are
presently taking a prescription drug for high blood
pressure or depression
Ask a doctor before use if you have
heart disease high blood pressure
thyroid disease diabetes diffculty 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

INACTIVE INGREDIENT

methylparaben,propylparaben,starch

Store at room temperature or in a cool place
but not over 80° F

KEEP OUT OF REACH OF CHILDREN

Label of box

PHENYLEPHRINE HYDROCHLORIDE 
phenylephrine hydrochloride suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58401-102
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER85.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STARCH, CORN (UNII: O8232NY3SJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58401-102-122 g in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product09/03/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34609/03/201408/30/2016
Labeler - Aditya Labs Inc (078610697)
Registrant - Aditya Labs Inc (078610697)
Establishment
NameAddressID/FEIBusiness Operations
Aditya Labs Inc078610697manufacture(58401-102)

Revised: 5/2017
 
Aditya Labs Inc