HEMORRHOIDAL RECTAL

Dosage form: suppository
Ingredients: COCOA BUTTER 855mg in 1g, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1g, SHARK LIVER OIL 30mg in 1g
Labeler: Generics Bidco I, LLC dba Qualitest Pharmaceuticals
NDC Code: 0603-0524

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.

ACTIVE INGREDIENT

(IN EACH SUPPOSITORY) COCOA BUTTER 85.5%  PROTECTANT, PHENYLEPHRINE HCL 0.25%   VASOCONSTRICTOR, SHARK LIVER OIL 3.0%  PROTECTANT

INACTIVE INGREDIENTS

METHYLPARABEN, PROPYLPARABEN, CORN STARCH

PURPOSE SECTION

FOR TEMPORARY RELIEF FROM PAIN AND ITCHING OF HEMMORRHOIDS

USES

TEMPORARILY RELIEVES HEMORRHOID SYMPTOMS, BURNING, ITCHING, DISCOMFORT, TEMPORARILY SHRINKS HEMORRHOIDAL TISSUE

DOSAGE AND ADMINISTRATION

DIRECTIONS ADULTS: IF POSSIBLE, CLEAN THE AFFECTED AREA BT PATTING OR BLOTTING WITH AN APPROPRIATE CLEANSING PAD  GENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLYING  REMOVE WRAPPER BEFORE INSERTING INTO THE RECTUM AS FOLLOWS: HOLD SUPPOSITORY WITH ROUND END UP  SEPARATE PLASTIC WRAP BY INSERTING TIP OF FINGERNAIL AT END MARKED "PEEL DOWN"  PEEL PLASTIC WRAP SLOWLY AND EVENLY DOWN BOTH SIDES, EXPOSING SUPPOSITORY  REMOVE EXPOSED SUPPOSITORY FROM WRAPPER  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: ASK A DOCTOR

OTHER INFORMATION  STORE AT ROOM TEMPERATURE OR IN A COOL PLACE BUT NOT OVER 80 DEGREES F (27 DEGREES C)

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

WARNINGS

WARNINGS  FOR RECTAL USE ONLY  ASK A DOCTOR  BEFORE USE IF YOU HAVE HEART DISEASE THYROID DISEASE HIGH BLOOD PRESSURE DIABETES TROUBLE URINATING DUE TO AN ENLARGED PROSTRATE GLAND

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE PRESENTLY TAKING A PRESCRIPTION DRUG FOR HIGH BLOOD PRESSURE OR DEPRESSION

WHEN USING THIS PRODUCT DO NOT USE MORE THAN DIRECTED

STOP USE AND ASK A DOCTOR IF SYMPTOMS GET WORSE OR DO NOT GET BETTER IN 7 DAYS  BLEEDING OCCURS

IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

TAMPER EVIDENT: DO NOT USE IF WRAPPER IS TORN OR OPENED

PACKAGE LABEL

HEMORRHOIDAL RECTAL SUPPOSITORIES NDC 0603-0524-11

MADE IN THE USA FOR QUALITEST PHARMACEUTICALS 130 VINTAGE DRIVE HUNTSVILLE AL 35811 REV. 0610

12 SUPPOSITORIES

HEMORRHOIDAL RECTAL  
phenylephrine hydrochloride suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0524
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (COCOA BUTTER) COCOA BUTTER855 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
SHARK LIVER OIL (SHARK LIVER OIL) SHARK LIVER OIL30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN  
PROPYLPARABEN  
STARCH, CORN  
Packaging
#Item CodePackage Description
1NDC:0603-0524-2112 POUCH (SUPPOSITORY) in 1 BOX
1NDC:0603-0524-112 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/01/2007
Labeler - Generics Bidco I, LLC dba Qualitest Pharmaceuticals (011103059)
Registrant - Generics Bidco I, LLC dba Qualitest Pharmaceuticals (011103059)

Revised: 05/2011
 
Generics Bidco I, LLC dba Qualitest Pharmaceuticals

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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