FDA Label for Cold, Flu And Sore Throat Maxium Strength

View Indications, Usage & Precautions

Cold, Flu And Sore Throat Maxium Strength Product Label

The following document was submitted to the FDA by the labeler of this product Demoulas Market Basket. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Factsactive Ingredients (In Each 20 Ml)



Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifensin 400 mg
Phenylephrine HCL 10 mg


Purpose



Pain reliever/Fever reducer
Cough suppressant
Expectorant
Nasal decongestant


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.


Uses



temporarily relieves these common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • 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 acetaminophen. Sever 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 daily 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 drugs 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
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

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



  • 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 persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding



ask a health professional before use


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 dose cup
  • mL = milliliter
  • do not take more than 6 doses in any 24-hour period
  • Age - Adults and children 12 years and older       Dose - 20 mL every 4 hours

    Age - Children under 12 years of age                  Dose - Do not use


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 and C Blue  #1, FD and 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 at

1-877-798-5944


Cold , Flu & Sore Throat Product Label



"MORE FOR YOUR DOLLAR"

MARKET BASKET
*COMPARE TO THE INGREDIENTS IN MUCINEX® FAST-MAX COLD™, FLU AND SORE THROAT

Cold, Flu and Sore Throat

Maximum Strength

Acetaminophen
Pain Reliever/Fever Reducer

Dextromethorophan HBr
Cough Suppressent

Guaifenesin Expectorant

Phenylephrine HCL
Nasal Decongestant

Relieves Fever and Body Aches
Controls Cough
Thins and Loosens Mucus
Relieves Nasal and Chest Congestion

6 FL OZ (177mL)

Adults
For Ages 12 and Over

*This product is not manufactures or distributed bt Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Cold, Flu and Sore Throat.
Peel Corner to Read Complete Drug Facts and Information

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

Failure to follow these warnings could result in consequences

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

LB-008 Rev 01

Lot:
Exp:


* Please review the disclaimer below.