Maximum Strength Mucus Relief Liquid
FDA Label NDC 83324-143

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Maximum Strength Mucus Relief (NDC 83324-143). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 20 ml), purpose, use(s), warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients (in Each 20 Ml)

→ Purpose

→ Use(s)

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If

→ When Using This Product

→ Stop Use And Ask Doctor If

→ If Pregnant Or Breast Feeding

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Active Ingredients (In Each 20 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCI 10 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Use(S)

temporarily relieves these common cold and flu symptoms:

sore throat
nasal congestion
minor aches and pains
headache
cough due to minor throat and bronchial irritation
sinus congestion and pressure

temporarily reduces fever
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes 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 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 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

• 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 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 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, fever 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
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor
Adults and children 12 years 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: sodium 15 mg
• store between 15-30°C (59-86°F)
• do not refrigerate
• dosing cup provided

Inactive Ingredients

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