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

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HistaFlex

Allegis Pharmaceuticals, LLC

HistaFlex


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each tablet) Purpose
Acetaminophen 325 mg Pain Reliever
Pyrilamine Maleate 25 mg Antihistamine

HistaFlex Uses

Temporarily relieves

  • minor aches and pains
  • backache
  • muscle aches
  • headache
  • cramps
  • bloating

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take;
  • more than 3,000 mg of acetaminophen in 24 hours;
  • with other drugs containing acetaminophen;
  • 3 or more alcoholic drinks everyday while using this product
  • Do not exceed recommended dosage.

Do not use this product

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you the user is taking

  • sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse,or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 2 tablets by mouth every 6 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor
Children under 12 years of age: Consult a doctor.

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Question? Comments?

Call 1-866-633-9033

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 28595-780-01

HistaFlex Tablets

Each tablet contains:
Acetaminophen
325 mg
Pyrilamine Maleate
25 mg

Caffeine Free
Multi-Symptom Relief of Cramps,
Backache, Headache, and Bloating

100 Tablets

HistaFlex

HistaFlex

ACETAMINOPHEN and PYRILAMINE MALEATE TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:28595-780
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
PYRILAMINE MALEATE PYRILAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
WHITE 16 mm 780 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:28595-780-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2014-05-22


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Be sure to consult your doctor before taking any medication!
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