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

FDA Label for Max Cold, Flu, And Sore Throat

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS ACTIVE INGREDIENTS
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN.
    4. USES
    5. WARNINGS
    6. WARNING
    7. DO NOT USE
    8. ASK A DOCTOR BEFORE USE IF YOU HAVE
    9. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    10. WHEN USING THIS PRODUCT
    11. STOP USE AND ASK A DOCTOR IF
    12. IF PREGNANT OR BREAST FEEDING
    13. OVERDOSE WARNING
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS?
    18. PRODUCT LABEL

Max Cold, Flu, And Sore Throat Product Label

The following document was submitted to the FDA by the labeler of this product H E B. 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 Facts Active Ingredients



Active ingredients (in each 20 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 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 awaay.


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 loosed phlegm (mucus) ang thin bronchial secretions to drain bronchial tubes


Warnings



Liver warnings: 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 daily while using this product


Warning



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 taking  a prescription monamine 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 or empysema
  • 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 the 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



Age                                                                                  Dose

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

Children under 12 years of age                                           Do not use



Other Information



  • each 20 mL contains: sodium 10 mg
  • dosage cup provided
  • store between 20°-25° C (68°-7°7 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


Product Label



Compare to Mucinex® FAST-MAX™  Cold, Flu and Sore Throat

NDC 37808-316-25

H E B®

MAX COLD, FLU AND SORE THROAT

Acetaminophen
(Pain Reliver/Fever Reducer)
Dextromethorphan HBr
(Cough Suppressant)
Guaifensin
(Expectorant)
Phenylephrine HCL
(Nasal Decongestant)

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

6 FL OZ (117 mL)

LF-002

Adults
For ages 12 and Over

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

GUARANTEE
We believe the high quality of this H-E-B product makes it an outstanding value. We hope you'll agree. If not, we'll cheerfully refund your money. Thanks for shopping with us.

LB-001208

Lot:
Exp:

*This product is not manufactured or distributed by Reckitt Benckiser Inc., distributer of Mucinex® FAST-MAX™ Cold, Flu, and Sore Throat.
MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TEXAS 78204






* Please review the disclaimer below.