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  5. Label Information: Theraflu Relief Max Strength Nighttime

FDA Label for Theraflu Relief Max Strength Nighttime

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH PACKET)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Theraflu Relief Max Strength Nighttime Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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.

Active Ingredients (In Each Packet)



Acetaminophen 1000 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg


Purposes



Pain reliever/Fever reducer

Antihistamine

Cough suppressant


Uses



  • ▪temporarily relieves these symptoms due to a common cold:
    • ▪headache
    • ▪minor aches and pains
    • ▪cough due to minor throat and bronchial irritation
    • ▪minor sore throat pain
    • ▪runny nose
    • ▪temporarily reduces fever

Warnings



Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • ▪more than 4,000 mg of acetaminophen in 24 hours
  • ▪with other drugs containing acetaminophen
  • ▪3 or more alcoholic drinks every day while using this product

    • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • ▪skin reddening
    • ▪blisters
    • ▪rash

      • If a skin reaction occurs, stop use and seek medical help right away.

      Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.


Do Not Use



  • ▪in a child under 12 years of age
  • ▪if you are allergic to acetaminophen
  • ▪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 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. If you do not know if your prescription drug contains a MAO, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have



  • ▪liver disease
  • ▪glaucoma
  • ▪trouble urinating due to an enlarged prostate gland
  • ▪a breathing problem such as emphysema or chronic bronchitis
  • ▪cough that occurs with too much phlegm (mucus)
  • ▪cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are



  • ▪taking the blood thinning drug warfarin
  • ▪taking sedatives or tranquilizers

When Using This Product



  • ▪avoid alcoholic drinks
  • ▪marked drowsiness may occur
  • ▪alcohol, sedatives, and tranquilizers may increase drowsiness
  • ▪be careful when driving a motor vehicle or operating machinery
  • ▪excitability may occur, especially in children

Stop Use And Ask A Doctor If



  • ▪pain or cough gets worse or lasts more than 7 days
  • ▪fever gets worse or lasts more than 3 days
  • ▪redness or swelling is present
  • ▪new symptoms occur
  • ▪cough comes back or occurs with rash or headache that lasts.
  •  These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



  • ▪do not use more than directed
  • ▪take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
    • AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not use
     
     
     
     
     
     
    • ▪dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
    • ▪if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat

Other Information



  • •each packet contains: potassium 6 mg
  • •store at room temperature. Protect from excessive heat and moisture.

Inactive Ingredients



anhydrous citric acid, Caramel, flavor, maltodextrin, potassium chloride, silica, sucralose, sucrose


Questions Or Comments?



1-866-467-2748


Principal Display Panel



*Compare to the active ingredients in Theraflu Multi-Symptom Flu Relief Max Strength** Nighttime

NDC 51316-549-06

Nighttime

Flu Relief

MAX STRENGTH**

Acetaminophen Pain Reliever/Fever Reducer

Chlorpheniramine Maleate Antihistamine

Dextromethorphan HBr Cough Suppressant

Honey Lemon

Natural & Artificial Flavored

1 SINGLE DOSE

TO OPEN: CUT ALONG DOTTED LINE WITH SCISSORS DO NOT USE IF SEALED PACKET IS TORN OR BROKEN

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Multi-Symptom Flu Relief Max Strength** Nighttime.

**Maximum Strength per 6 hours dose

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

Flu Relief Nighttime Powder - image 01

Flu Relief Nighttime Powder - image 01


* Please review the disclaimer below.