Miconazole 3 Combination Pack description, usages, side effects, indications, overdosage, supplying and lots more!

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Miconazole 3 Combination Pack

Major Pharmaceuticals


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Miconazole nitrate (200 mg in each suppository)
Miconazole nitrate 2% (external cream)

Vaginal antifungal

  • treats vaginal yeast infections
  • relieves external itching and irritation due to a vaginal yeast infection

For vaginal use only

If you have never had a vaginal yeast infection diagnosed by a doctor

  • vaginal itching and discomfort for the first time
  • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
  • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
  • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

  • do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
  • do not have vaginal intercourse
  • mild increase in vaginal burning, itching or irritation may occur
  • symptoms do not get better in 3 days
  • symptoms last more than 7 days
  • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

Ask a health professional before use.

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

  • before using this product read the enclosed consumer information leaflet for complete directions and information
  • adults and children 12 years of age and over:
    • suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
    • external cream: use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.
  • children under 12 years of age:  ask a doctor

Other Information

  • do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
  • do not use if seal over tube opening has been punctured or is not visible
  • do not purchase if carton is open
  • store at room temperature 15º - 30ºC (59º - 86ºF). Avoid heat (over 30ºC- 86ºF)
  • suppository: hydrogenated vegetable oil
  • external cream: benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Questions ?

 1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday - Friday.

Major®

3DAY TREATMENT
PLUS CREAM FOR EXTERNAL RELIEF

NDC 0904-5415-01

MICONAZOLE 3
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES (200 MG) &
MICONAZOLE NITRATE CREAM, 2%

VAGINAL ANTIFUNGAL
COMBINATION PACK

CURES MOST VAGINAL YEAST INFECTIONS AND
RELIEVES ASSOCIATED EXTERNAL ITCHING & IRRITATION

(MICONAZOLE NITRATE 200 mg PER SUPPOSITORY PLUS 2% EXTERNAL VULVAR CREAM)

COMPARE TO the active ingredient of Monistat® 3*

3 VAGINAL SUPPOSITORIES WITH 3 DISPOSABLE APPLICATORS PLUS
EXTERNAL VULVAR CREAM

NET WT. 3 SUPPOSITORIES + 0.32 oz (9 g) tube

Miconazole 3 Combination Pack
Major Miconazole 3

Miconazole 3 Combination Pack

miconazole nitrate KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5415
Route of Administration VAGINAL DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5415-01 1 in 1 PACKAGE, COMBINATION

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074926 2002-12-02


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