Multi Symptom Severe Cold
FDA Label NDC 55319-547

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services Inc for the product Multi Symptom Severe Cold (NDC 55319-547). 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), 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 (In Each Packet)

Acetaminophen 500 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever / fever reducer

Cough Suppressant

Nasal Decongestant

Uses

  • ▪temporarily relieves these symptoms due to a cold:
  • ▪minor aches and pains

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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • ▪liver disease
  • ▪heart disease
  • ▪high blood pressure
  • ▪thyroid disease
  • ▪diabetes
  • ▪trouble urinating due to an enlarged prostate gland
  • ▪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

  • ▪nervousness, dizziness, or sleeplessness occurs
  • ▪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 fever, rash or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health care 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 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 6 mg
  • ▪Aspartame free, sodium free
  • ▪store at room temperature. Protect from excessive heat and moisture.

Inactive Ingredients

citric acid, caramel, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,

Questions Or Comments

1-866-467-2748

Principal Display

Multi-symptom Severe Cold Honey Lemon 6 Packets (Image 01)

Multi-symptom Severe Cold Honey Lemon 6 Packets (Image 01)

Compare to the active ingredients in Theraflu Multi-Symptom Severe Cold*

NDC 55319-547-06

MULTI-SYMPTOM

SEVERE COLD

Acetaminophen

Pain Reliever/ Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

Dye Free

  •  Relieves
    • cough
    • Nasal congestion
    • Sore throat pain
    • Headache
    • Body ache
    • Fever

      • Honey Lemon

      6 PACKETS

      TAMPER EVIDENT INNER UNIT: 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 Severe Cold.

* Please review the disclaimer below.