Theraflu Severe Cold Relief Daytime Powder, For Solution
FDA Label NDC 70264-047

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by R J General Corporation for the product Theraflu Severe Cold Relief Daytime (NDC 70264-047). 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 (in each packet), uses, warnings, do not use, ask doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients (In Each Packet)

Active ingredients (in each tablet)Purpose
Acetaminophen 500 mgPain reliever/Fever reducer
Dextromethorphan HBr 20 mgCough Suppressant

Uses

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • cough due to minor throat and bronchial irritation
    • 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 a 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 Doctor Before Use If You Have

  • liver disease
  • 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

Stop Use And Ask A Doctor If

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

Directions

  • do not use more than directed
  • take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor.
  • Age

    Dose

    adults and children

    12 years of age and over

    one packet

    children under

    12 years of age

    do 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 10 mg, sodium 20 mg
  • phenylketonurics:contains phenylalanine 20 mg per packet
  • store at controlled room temperature 20 o-25 oC (68 o- 77 oF). Protect product from heat and moisture.

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no.10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Questions Or Comments?

1-855-328-5259

Principal Display Panel

THERAFLU SEVERE COLD RELIEF - Acetaminophen, Dextromethorphan HBr - NDC 70264-047-01 - 25s Packets Caton Label

Image Description (Theraflu 25s Packets Carton Label)

Image Description (Theraflu 25s Packets Carton Label)

* Please review the disclaimer below.