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

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Miconazole 3 Combination Pack

Fred's Inc.

3 Day TreatmentMiconazole 3Vaginal Antifungal




FULL PRESCRIBING INFORMATION

DRUG FACTS

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

Do not use 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

Ask a doctor or pharmacist before use if you are 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

If pregnant or breast-feeding, 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.

  • 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
  • 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 15°- 30°C (59°- 86°F). Avoid heat (over 30°C- 86°F)
  • suppository: hydrogenated vegetable oil
  • external cream: benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

1-800-432-8534 between 9 am and 4pm EST, Monday- Friday.

Fred’s®
3 Vaginal Suppositories with Disposable
Applicators plus External Cream

Miconazole 3
Combination Pack
Miconazole Nitrate Vaginal Suppositories, USP 200 mg
and Miconazole Nitrate External Vulvar Cream, 2%

Vaginal Antifungal
Cures Most Vaginal Yeast Infections
Relieves Associated External Itching & Irritation

3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg
plus 1 tube of Miconazole Nitrate External
Vulvar Cream – Net Wt 0.32 oz (9g)

Compare to the active ingredients in:

Monistat® 3 

Miconazole 3 Combination Pack

Miconazole 3 Combination Pack

Miconazole Nitrate KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55315-731
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55315-731-43 1 in 1 PACKAGE, COMBINATION

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074926 2009-06-09


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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