Theraflu Relief Max Strength Powder, For Solution
FDA Label NDC 51316-539

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Theraflu Relief Max Strength (NDC 51316-539). 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 active ingredients (each packet), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (Each Packet)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Purposes

Pain reliever/Fever reducer

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
    • ▪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 an 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
  • ▪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

When Using This Product

  • ▪do not exceed recommended dosage.

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 at 1-800-222-1222. 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 the entire drink within 10-15 minutes.
    • ▪if using a microwave, add contents of one packet to 8 oz. of cool water: sip 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, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose

Questions Or Comments?

1-866-467-2748

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

NDC 51316-539-06

Daytime

Flu Relief

MAX STRENGTH**

Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Honey Lemon Flavor

1 SINGLE DOSE

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

**Maximum Strength per 6 hour dose

Manufactured by:

Raritan Pharmaceuticals,

8 Joanna Court, East Brunswick, NJ 08816

* Please review the disclaimer below.