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  5. Label Information: Cold, Flu, And Sore Throat

FDA Label for Cold, Flu, And Sore Throat

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH LIQUID GEL)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OF PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Cold, Flu, And Sore Throat Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution Inc. 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.

Active Ingredients (In Each Liquid Gel)



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg


Purposes



Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant


Uses



  • •temporarily relieves these common cold and flu symptoms:
  • •nasal congestion
  • •headache
  • •cough
  • •minor aches and pains
  • •sore throat
  • •temporarily reduces fever
  • •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 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.
  • •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
  • •diabetes
  • •high blood pressure
  • •thyroid disease
  • •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 Of 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
  • •pain, nasal congestion or cough gets worse or lasts more than 7 days
  • •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



  • •do not take more than directed (see Overdose warning)
  • •do not take more than 10 liquid gels in any 24-hour period
  • •adults and children 12 years of age and older: take 2 liquid gels every 4 hours

    • children under 12 years of age: do not use


Other Information



store at 20-25°C (68-77°F)


Inactive Ingredients



edible ink*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to Mucinex® Fast-Max® Cold, Flu & Sore Throat active ingredients

NON-DROWSY

MAXIMUM STREGNTH

cold, flu & sore throat

Acetaminophen | Pain Reliever | Fever Reducer

Dextromethorphan HBr | Cough Suppressant

Guaifenesin | Expectorant

Phenylephrine HCl | Nasal Decongestant

Fast Dissolving Liquid Gels

16 Liquid Gels

(Liquid Filled Capsules)

actual size

Controls Cough, Thins and Loosens Mucus

Relieves Nasal and Chest Congestion

Relieves Headache and Fever

For Ages 12+

cold-flu-sore-throat.jpg - image 01

cold-flu-sore-throat.jpg - image 01


* Please review the disclaimer below.