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Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Bronchitis Common Cold Laryngitis Pharyngitis Rhinitis, Allergic, Perennial Sinusitis Whooping Cough Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular


IMPRINT: AR01     SHAPE: oval
    COLOR: orange

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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

Active ingredients (in each liquid gel) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • headache
    • cough
    • stuffy nose
    • minor aches and pains
    • sore throat
    • sinus congestion and pressure
  • temporarily reduces fever
  • helps loosen phelegm (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 12 liquid gels 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
  • bulers
  • 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 (precription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a precription 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 precription 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
  • persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION


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

OTC - WHEN USING SECTION


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 fever, rash, or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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 liquid gels in any 24-hour period
  • adults and children 12 years of age and over: take 2 liquid gels every 4 hours
  • children under 12 years of age: do not use

Other Information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat

Inactive Ingredients


FD&C yellow no. 6, gelatin, glycerin, hypromellose, isopropyl alcohol, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, water

Questions?


1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.


Dist. by: RB Health (US) Parsippany, NJ 07054-0224

Principal Display Panel - 16 Capsule Blister Pack Carton


Fast Dissolving Liquid Gels!

NDC 72854-126-16

MAXIMUM STRENGTH

MUCINEX® FAST-MAX ®

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Guaifenesin – Expectorant Phenylephrine HCl – Nasal Decongestant

HEADACHE SORE THROAT CHEST CONGESTION BODY PAIN FEVER COUGH NASAL CONGESTION SINUS CONGESTION SINUS PRESSURE

ALL IN ONE*

16 LIQUID GELS (Liquid Filled Capsules)

Actual Size

FOR AGES 12 +

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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