HISTAFLEX- acetaminophen and pyrilamine maleate tablet 
Allegis Pharmaceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HistaFlex

Drug Facts

Active ingredients (in each tablet)Purpose
Acetaminophen 325 mgPain Reliever
Pyrilamine Maleate 25 mgAntihistamine

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

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
HISTAFLEX 
acetaminophen and pyrilamine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28595-780
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE25 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize16mm
FlavorImprint Code 780
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:28595-780-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/22/201412/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/22/201412/31/2019
Labeler - Allegis Pharmaceuticals, LLC (792272861)

Revised: 1/2020
 
Allegis Pharmaceuticals, LLC