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

APJ HEMORRHOIDAL

A P J Laboratories Limited
A P J Laboratories Limited

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

PHENYLEPHRINE HYDROCHLORIDE

PETROLATUM

MINERAL OIL

Purpose


Protectant

Vasoconstrictor

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

■ Helps relieve the local itching and discomfort associated with hemorrhoids.

■ Temporarily shrinks hemorrhoidal tissue and relieves burning.

■ Temporarily provides a coating for relief of anorectal discomforts.

■ Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.


For external and/or intrarectal use only



■adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment.

■when first opening the tube, puncture foil seal with top end of cap

■apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

■intrarectal use:

    ■remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum

    ■thoroughly cleanse applicator after each use and replace cover

■also apply ointment to external area

■regular use provides continual therapy for relief of symptoms

■children under 12 years of age: ask a doctor




PARAFFIN

BUTYLATED HYDROXYTOLUENE

METHYLPARABEN

PROPYLPARABEN

CHLOROCRESOL

LANOLIN

MAGNESIUM STEARATE

LIGHT MINERAL OIL

DISPLAY PANEL

DISPLAY PANEL

APJ HEMORRHOIDAL

PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:46084-111
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 2.55 mg
petrolatum 720 mg
Mineral Oil 140 mg

Inactive Ingredients

Ingredient Name Strength
PARAFFIN
BUTYLATED HYDROXYTOLUENE
METHYLPARABEN
PROPYLPARABEN
chlorocresol
LANOLIN
MAGNESIUM STEARATE
LIGHT MINERAL OIL

Product Characteristics

Color
white (OFF WHITE)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:46084-111-10 28 in 1 TUBE
2 NDC:46084-111-20 57 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2013-07-01


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Be sure to consult your doctor before taking any medication!
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