FDA Label for Mucosan Max With Acetaminophen

Otc - Active Ingredient

Active Ingredients (in each 20 mL) Purpose

Acetaminophen, 650 mg................................Pain reliever/Fever reducer

Dextromethorphan HBr, 20 mg......................Cough suppressant

Guaifenesin, 400 mg.............................. .......Expectorant

Phenylephrine HCl, 10 mg.............................Nasal Decongestant

Otc - Purpose

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal Decongestant

Indications & Usage

Uses

• temporarily relieves these common cold and flu symptoms:
• nasal congestion
• cough
• minor aches and pains
• sore throat
• headache
• temporarily reduces fever
• helps loosen phlem (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Warnings

Liver warning: this product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 4 doses (20 mL each) in 24 hours, wich is the maximum daily amount for this product
• 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 and rash. If 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.

Otc - Do Not Use

Do not use

• With any other drug containing acetamonophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
• if you are 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 a MAOI, ask a doctor or Pharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - When Using

When using this product do not use more than direct.

Otc - Stop Use

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough comes back or occurs with fever, rash, or persistant headache
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast - feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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 even if you do not notice any signs or symptoms.

Dosage & Administration

Directions

• do not take more than direct
• do not take more than 4 doses in any 24 hours
• this adult strength product is not intended for use in children under 12 years of age
• measure only with dosing cup provided
• keep dosing cup with product
• mL = milliliter
• dose as follows

age	dose
adults and children 12 years of age and older	20 mL every 4 hours
children under 12 years of age	do not use

Other Safety Information

Other information

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

Inactive Ingredient

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.

Otc - Questions

Questions or comments?

1-800-560-5223 Monday to Friday 9am-4pm, Eastern Time