Cold Flu Solution
FDA Label NDC 42507-532

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hyvee Inc for the product Cold Flu (NDC 42507-532). 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 15 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Uses

  • temporarily relieves common cold/flu symptoms:
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

Warnings

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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

  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough 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

  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed – see Overdose warning
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

    • adults & children 12 yrs & over

    30 mL every 4 hrs

    children 6 to under 12 yrs

    15 mL every 4 hrs

    children 4 to under 6 yrs

    ask a doctor

    children under 4 yrs

    do not use

Other Information

  • each 15 mL contains: sodium 12 mg
  • store at 20-25°C (68-77°F)

Inactive Ingredients

anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions?

1-800-289-8343

Package/Label Principal Display Panel

Compare To Vicks® DayQuil® Cold & Flu Active Ingredients

Hy•Vee®

Multi-Symptom Relief

Cold & Flu

Daytime • Non-Drowsy

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

• Headache

• Fever, Sore Throat

• Minor Aches & Pains

• Cough

Elderberry Flavor

ALCOHOL & ANTIHISTAMINE FREE

12 FL OZ (355 mL)

Cold-flu-pdp (Cold Flu Front Label)

Cold-flu-pdp (Cold Flu Front Label)

Cold-flu-dfl (Cold Flu Back Label)

Cold-flu-dfl (Cold Flu Back Label)

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