FDA Label for Mucus Relief Cold Flu And Sore Throat Maximum Strength

Active Ingredients (In Each 20 Ml)

Acetaminophen 650 mg 

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer 

Cough suppressant

Expectorant

Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • headache
  • sinus congestion and pressure
  • sore throat
  • minor aches and pains
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • 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 6 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday 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.
• for children under 12 years of age
• 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.

Ask A Doctor Before Use If You Have

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

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

• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
• new symptoms occur
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• cough comes back, or occurs with rash or persistent 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.

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

• do not take more than directed (see overdose warning)
• do not take more than 6 doses in any 24-hour period
• measue only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• mL = milliliter
• adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
• children under 12 years of age: do not use

Other Information

• each 20 mL contains: sodium12 mg
• store between 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, disodium EDTA,, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

Call toll free 1-888-423-0139

Principal Display Panel

Maximum Strength

Mucus Relief

Cold, Flu & Sore Throat

Multi-Symptom Relief

• Aches & Fever - Acetaminophen
• Cough - Dextromethorphan HBr
• Chest Congestion & Mucus - Guaifenesin
• Stuffy Nose - Phenylephrine HCl

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

For ages 12 & over

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, Distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore throat.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected]

www.topcarebrand.com

Package Label