HEMORRHOIDAL RECTAL description, usages, side effects, indications, overdosage, supplying and lots more!

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HEMORRHOIDAL RECTAL

Generics Bidco I, LLC dba Qualitest Pharmaceuticals
Generics Bidco I, LLC dba Qualitest Pharmaceuticals


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

HEMORRHOIDAL RECTAL 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

HEMORRHOIDAL RECTAL

PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0603-0524
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
COCOA BUTTER 855 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg
SHARK LIVER OIL 30 mg

Inactive Ingredients

Ingredient Name Strength
METHYLPARABEN
PROPYLPARABEN
STARCH, CORN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0603-0524-11 2 in 1 POUCH
2 NDC:0603-0524-21 12 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2007-01-01


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Be sure to consult your doctor before taking any medication!
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