Relief-pe
FDA Label NDC 50332-0127

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Normed for the product Relief-pe (NDC 50332-0127). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding indications & usage, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Indications & Usage

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

Warnings

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

Otc - Do Not Use

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

Otc - Ask Doctor/Pharmacist

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

Otc - Ask Doctor

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

Otc - When Using

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.

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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.

Dosage & Administration

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

Otc - Active Ingredient

Active Ingredients (in each tablet)

Acetaminophen 325mg...pain reliever/fever reducer

Phenylephrine 5mg...nasal decongestant

chlorpheniramine maleate 2mg...antihistimine

Otc - Purpose

Pain Reliever/Fever Reducer

Nasal Decongestant

Antihistamine

Inactive Ingredient

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

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