Mucus Relief Fm

Mucus Relief Fm
SPL v1
SPL
SPL Set ID c5851b74-5af7-488f-b093-7f34a917934e
Route
ORAL
Published
Effective Date 2014-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Colloidal Silicon Dioxide Croscarmellose Sodium Crospovidone Fd&c Blue No. 1 Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Polyethylene Glycols Polyvinyl Alcohol Povidone Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-04-04

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer Cough Suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/Fever reducer

Cough Suppressant

Expectorant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Pdp

Health Mart

compare to Mucinex Fast-MaxTM Cold, Flu and Sore Throat active ingredients

for ages 12+

mucus relief FM

adult cold, flu and sore throat

acetaminophen.....pain reliever/Fever reducer

dextromethorphan HBr.....cough Suppressant

guaifenesin....expectorant

phenylephrine HCl.....nasal congestion

soothing relief for headache, fever, cough, nasal and chest congestion

thins and loosens mucus

20 Caplets

Uses
  • temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • cough
  • headache
  • sore throat
  • minor aches and pains
  • temporarily reduces fever
  • helps loosen (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.
Section 50565-1

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

Inactive Ingredients

Colloidal silicon dioxide, croscaramellose sodium, crospovidone, FD&C blue 1 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide. May contain methacrylic acid copolymer, sodium bicarbonate

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.

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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


Structured Label Content

Pdp (PDP)

Health Mart

compare to Mucinex Fast-MaxTM Cold, Flu and Sore Throat active ingredients

for ages 12+

mucus relief FM

adult cold, flu and sore throat

acetaminophen.....pain reliever/Fever reducer

dextromethorphan HBr.....cough Suppressant

guaifenesin....expectorant

phenylephrine HCl.....nasal congestion

soothing relief for headache, fever, cough, nasal and chest congestion

thins and loosens mucus

20 Caplets

Uses
  • temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • cough
  • headache
  • sore throat
  • minor aches and pains
  • temporarily reduces fever
  • helps loosen (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.
Section 50565-1 (50565-1)

Purpose

Pain reliever/Fever reducer

Cough Suppressant

Expectorant

Nasal decongestant

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
  • 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.
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
Do Not Use (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.
Other Information (Other information)
  • tamper evident: do not use if individual blister units are borken or open
  • store between 15-30oC(59-86oF)
Overdose Warning: (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.

Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, croscaramellose sodium, crospovidone, FD&C blue 1 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide. May contain methacrylic acid copolymer, sodium bicarbonate

When Using This Product (When using this product)

do not use more than directed

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use. Keep out of reach of children.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if)

you are taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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