STAFLEX- acetaminophen and brompheniramine maleate tablet 
Magna Pharmaceuticals, Inc.

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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STAFLEX™

Drug Facts

Active Ingredients (in each tablet)Purpose
Acetaminophen 250 mgPain Reliever/Fever Reducer
Brompheniramine Maleate 2 mgAntihistamine

Uses

temporarily relieves:

  • minor aches and pains
  • runny nose
  • sneezing
  • headache
  • temporarily reduces fever

Warnings

Do not exceed recommended dosage.

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

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 are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor before use if you are taking

  • sedatives or tranquilizers
  • 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

  • pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (Adults)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

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.

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

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:2 tablets by mouth every 4-6 hours, not to exceed 12 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:1 tablet every 4-6 hours, not to exceed 6 tablets in 24 hours, pr as directed by a doctor
Children under 6 years of ageConsult a doctor

Inactive ingredients

FD&C Yellow #6, D&C Yellow #10, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions or Comments?

Call 1-888-206-5525

www.magnaweb.com

Rev. 06/14

PRINCIPAL DISPLAY PANEL - 2 Tablet Blister Pack Carton

NDC 58407-225-02

Staflex™

Pain Reliever • Fever Reducer
Antihistamine

Contains Acetaminophen. Always read the label.

Each tablet contains:

Acetaminophen
250 mg

Brompheniramine Maleate
2 mg

MAGNA
Pharmaceuticals, Inc.
Louisville, KY 40299
888-206-5525
www.magnaweb.com
Carton contains 2 or more tablets

Principal Display Panel - 2 Tablet Blister Pack Carton
STAFLEX 
acetaminophen and brompheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58407-225
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorORANGEScore2 pieces
ShapeOVALSize13mm
FlavorImprint Code Staflex
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58407-225-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/24/201412/31/2017
2NDC:58407-225-021 in 1 BOX11/24/201412/31/2017
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/24/201412/31/2017
Labeler - Magna Pharmaceuticals, Inc. (620988360)

Revised: 12/2017
 
Magna Pharmaceuticals, Inc.