Cold And Sinus Liquid
FDA Label NDC 53942-515

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Demoulas Market Basket for the product Cold And Sinus (NDC 53942-515). 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 drug factsactive ingredients(in each 20 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

Drug Factsactive Ingredients(In Each 20 Ml)

Acetaminophen 650 mg
Guaifenesin 400 mg
Phenylephrine HCL 10 mg

Purpose

Pain reliever/Fever reducer
Expectorant
Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • sore throat
  • headache
  • fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Liver warning This product contains acetamnophen. 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

  • 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.
  • for children under 12 years of age

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning product warfarin.

When Using This Product

  • do not use more that directed

Stop Use And Ask A Doctor If

  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistant headache. 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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 recommended (see Overdose warning)
  • use dosage cup
  • mL = milliliter
  • do not take more han 6 doses in any 24-hour period

    • Age                                                  Dose

    Adults & children                               20 mL every 4 hours
    12 years and older

    Children under 12                             Do not use
    years of age

Other Information

  • each 20 mL contains: sodium 10 mg
  • dosage cup provided
  • store between 15-30 C (59-86 F)
  • do not refrigerate

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944

Cold And Sinus Product Label

Market Basket®
"MORE FOR YOUR MONEY"
* COMPARE TO
the active ingredients found in
MUCINEX® FAST-MAX™
COLD & SINUS

Cold & Sinus
MAXIUN STRENGTH

Acetaminophen


(Pain Reliever/Fever Reducer)

Guiafenesin (Expectorant)

Phenylephrine HCL
(Nasal Decongestant)

Relieves Fever & Body Aches
Thins & Loosens Mucus
Relieves Nasal & Chest Congestion

Adults For Ages 12 & Over

LF-009 Rev 01

6 FL OZ (177 mL)

Peel Corner to Read Completed Drug Facts and information

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Failure to follow these warnings could result in serious consequences.

DISTRIBUTED BY
DEMOULAS SUPERMARKETS INC.
875 East Street
TEWKSBURY, MA 01876

* This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Mucinex® FAST-MAX™ COLD & SINUS

* Please review the disclaimer below.