Relief-PE

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg, CHLORPHENIRAMINE MALEATE 2mg
Labeler: NorMed
NDC Code: 50332-0127

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.

Relief-PE

Temporarily relieves nasal congestion, sinus pressure, and minor aches and pains due to:

  • the common cold
  • hay fever
  • upper respiratory allergies
  • headache
  • itchy/watery eyes
  • runny nose
  • muscular aches
Temporarily reduces fever

Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take:
  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcohol drinks every day while using this product

Do not use:

  • with any other drug containing acetaminophen (prescription or non-prescription)
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug, or if you do not know if your prescription drug contains an MAOI

Ask a doctor or pharmacist before use if
  • you are taking sedatives or tranquilizers
  • you are taking the blood thinning drug warfarin
  • you do not know if other drugs you are taking contain acetaminophen

Ask a doctor before use if you have

  • heart, liver, or thyroid disease
  • high blood pressure
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

When using this product to not use more than directed. This product may cause excitability or drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Use caution when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • new symptom occur
  • fever worsens or lasts for more than 3 days
  • pain or nasal congestion gets worse or lasts more than 7 days
  • redness or swelling is present
These could be signs of serious condition

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

Keep out of reach of children.

Overdose warning: Taking mo rethan the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222.

Directions: Do not take more than directed. Adults and children 12 years of age an over:
  • take 1 to 2 tablets every 6 hours while symptoms persist
  • do not take more than 8 tablets in 24 hours unless directed by a doctor
Children under 12 years of age: do not use; this will provide more than the recommended does (overdose) and may cause liver damage

Active Ingredients (in each tablet)

Acetaminophen 325mg...pain reliever/fever reducer

Phenylephrine 5mg...nasal decongestant

chlorpheniramine maleate 2mg...antihistimine

Pain Reliever/Fever Reducer

Nasal Decongestant

Antihistamine


corn starch, hydroxpropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, stearic acid







RELIEF-PE 
acetaminophen, phenylephrine, chlorpheniramine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0127
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE5 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE2 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeAZ275
Contains    
Packaging
#Item CodePackage Description
1NDC:50332-0127-4100 TABLET, COATED (TABLET) in 1 BOX, UNIT-DOSE
2NDC:50332-0127-7250 TABLET, COATED (TABLET) in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/16/2012
Labeler - NorMed (069560969)

Revised: 04/2012
 
NorMed

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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