Healthmart Mucus Relief Fm
FDA Label NDC 62011-0218

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Healthmart Mucus Relief Fm (NDC 62011-0218). 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 caplet), purpose, otc - keep out of reach of children, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients (in Each Caplet)

→ Purpose

→ Otc - Keep Out Of Reach Of Children

→ Uses

→ 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 A Doctor If

→ If Pregnant Or Breast-feeding,

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Pdp

Active Ingredients (In Each Caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer

Cough Suppressant

Expectorant

Nasal decongestant

Otc - Keep Out Of Reach Of Children

Uses

temporarily relieves these common cold and flu symptoms:
nasal congestion
cough
headache
fever
minor aches and pains
sinus congestion and pressure
temporarily promotes nasal and/or sinus drainage
helps loosen (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 12 caplets in 24 hours, which is maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

Do Not Use

with any other drug containing acetaminophen (prescription or non prescription). 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.

Ask A Doctor Before Use If You Have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
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 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 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 12 caplets in any 24 hour period
Adults and children 12 years and older: take 2 caplets every 4 hours.
Children under 12 years of age: Do not use

Other Information

tamper evident: do not use if individual blister units are borken or open
store between 15-30^oC(59-86^oF)

Inactive Ingredients

Colloidal silicon dioxide, croscaramellose sodium, crospovidone, FD&C red 40 aluminum lake, FD&C yellow 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide. May contain methacrylic acid copolymer, sodium bicarbonate