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HEMORRHOID RELIEF by Rite Aid Corporation

Dosage form: suppository
Ingredients: COCOA BUTTER .855g in 1g, PHENYLEPHRINE HYDROCHLORIDE .0025g in 1g
Labeler: Rite Aid Corporation
NDC Code: 11822-0450

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 suppository)                                  Purpose


Cocoa Butter 85.5%........................................................................ Protectant
Phenylephrine HCL 0.25%............................................................... Vasoconstrictor




Active ingredients (in each suppository)                                  Purpose


Cocoa Butter 85.5%........................................................................ Protectant
Phenylephrine HCL 0.25%............................................................... Vasoconstrictor

________________________________________________________________________________________

Uses temporarily - Shrinks hemorrhoidal tissues - relieves itching, burning and discomfort associated with hemorrhoids


Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center right away.

Uses - shrinks hemorrhoidal tissues - relieves itching, burning and discomfort associated with hemorrhoids

Warnings
For rectal use only
____________________________________________________

Ask a doctor before use if you have - heart disease - high blood pressure
- thyroid disease - diabetes - difficulty in urination due to enlargement of the prostate gland
_____________________________________________________

Ask a doctor or pharmacist before use if you are - presently taking a prescription
drug for high blood pressure or depression
______________________________________________________

Stop use and ask a doctor if
- bleeding occurs - condition gets worse or does not improve within 7 days
______________________________________________________

If pregnant or breastfeeding, 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 - if possible, clean the affected area by patting or blotting with an appropriate cleansing pad
- gently dry by patting or blotting with toilet tissue or a soft cloth before insertion of this product
- detach one suppository from strip - remove wrapper before inserting into the rectum - hold suppository
with rounded end up and carefully peel film slowly and evenly down both sides to expose the suppository
- insert one suppository into rectum up to 4 times daily especially at night and morning or after each bowel
movement

Children under 12 years of age: ask a doctor
________________________________________________________________________________________

Other information - store at room temperature but not over 89 degrees F (32 degrees C)

Inactive Ingredients starch, shark liver oil, methylparaben, propylparaben

HEMORRHOID RELIEF 
cocoa butter, phenylephrine hydrochloride suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0450
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (COCOA BUTTER) COCOA BUTTER.855 g  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE.0025 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
SHARK LIVER OIL 
STARCH, CORN 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:11822-0450-612 PACKET (SUPPOSITORY) in 1 CARTON
12.5 g in 1 PACKET
2NDC:11822-0450-724 PACKET (SUPPOSITORY) in 1 CARTON
22.5 g in 1 PACKET
3NDC:11822-0450-848 PACKET (SUPPOSITORY) in 1 CARTON
32.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/01/2011
Labeler - Rite Aid Corporation (014578892)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIOperations
Pharma Pac, LLC140807475manufacture

Revised: 07/2011
 
Rite Aid Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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