Cold And Flu Relief Solution
FDA Label NDC 21130-436

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Cold And Flu Relief (NDC 21130-436). 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, 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 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • sinus congestion and pressure
  • nasal congestion
  • minor aches and pains
  • headache
  • sore throat
  • fever
  • cough due to minor throat and bronchial irritation
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

When Using This Product

do not use more than directed

Stop Use And Ask A Doctor If

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, 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 15 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, FD&C yellow #6, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions?

1-800-719-9260

Package/Label Principal Display Panel

COMPARE TO Vicks® DayQuil® Severe active ingredients

Signature SELECT™

DAYTIME SEVERE

COLD & FLU RELIEF

ACETAMINOPHEN 325 mg

Pain Reliever, Fever Reducer

DEXTROMETHORPHAN HBr 10 mg

Cough Suppressant

GUAIFENESIN 200mg

Expectorant

PHENYLEPHRINE HCl 5mg

Nasal Decongestant

MAXIMUM STRENGTH

ORIGINAL FLAVOR

LOVE IT OR IT’S ON US

ALCOHOL FREE

NON-DROWSY

12 FL OZ (355 mL)

Signature-select-cold-&-flu-relief-container-image.jpg (Image 01)

Signature-select-cold-&-flu-relief-container-image.jpg (Image 01)

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