Severe Cold And Cough Daytime Powder, For Solution
FDA Label NDC 67091-322

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Severe Cold And Cough Daytime (NDC 67091-322). 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 ingredient (in each packet), purposes, uses, warnings, do not use, ask 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 Ingredient (In Each Packet)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • nasal and sinus congestion
    • 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
  • 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 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 4 hours, while symptoms persist. Do not take more than 5 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
  • store at room temperature .Protect from excessive heat and moisture.

Inactive Ingredients

citric acid, aspartame, FD&C blue # 1, FD&C red # 40, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,

Questions Or Comments?

Call 800-824-1706

Monday-Friday 9am-4pm MST

Principal Display

*Compare to the active ingredients in THERAFLU® Daytime Severe Cold &Cold

WinCo FOODS

Severe Cold & Cough

Daytime

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUER

DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT

PHENYLEPHRINE HCl – NASAL DECONGESTANT

  • Relieves: Nasal Congestion, Sore Throat Pain, Cough, Headache, Body Ache & Fever

    • 6 PACKETS

    Berry Infused with Menthol & Green Tea Flavors

    READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

    KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

    TAMPER EVIDENT INNER UNIT

    DO NOT USE IF SEALED PACKET IS TORN OR BROKEN

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    Comments & Questions?

    800-824-1706 www.wincofoods.com

    DISTRIBUTED BY:

    WINCO FOODS, LLC,

    BOISE, ID 83704

    *This product is not manufactured or distributed by GSK consumer Healthcare, owner of the registered trademark THERAFLU® Daytime Severe Cold & Cough.

* Please review the disclaimer below.