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  5. Label Information: Relief-pe

FDA Label for Relief-pe

View Indications, Usage & Precautions

Table of Contents

    1. INDICATIONS & USAGE
    2. WARNINGS
    3. OTC - DO NOT USE
    4. OTC - ASK DOCTOR/PHARMACIST
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. OVERDOSAGE
    11. DOSAGE & ADMINISTRATION
    12. OTC - ACTIVE INGREDIENT
    13. OTC - PURPOSE
    14. INACTIVE INGREDIENT
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Relief-pe Product Label

The following document was submitted to the FDA by the labeler of this product Normed. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

Package Label.Principal Display Panel










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