Mucinex fast-max congestion and headache tablet, coated

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Drug Facts

Otc - active ingredient section

Otc - purpose section

Active Ingredients (in each caplet) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • fever
    • headache
    • minor aches and pains
    • sinus congestion and pressure
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (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 caplets 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.

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.
  • 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)

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you aretaking 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 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 caplets in any 24-hour period
  • adults and children 12 years of age and older: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Other information

  • store between 20-25C (68-77F)

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Questions?

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

You may also report side effects to this phone number.

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Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
Made in England

Ingredients and appearance - Product information

Mucinex fast-max congestion and headache tablet, coated- Acetaminophen, guaifenesin, and phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 63824-236
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 200 mgin 1
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Aluminum oxide ( UNII: LMI26O6933)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Polyvinyl alcohol, unspecified ( UNII: 532B59J990)
Povidones ( UNII: FZ989GH94E)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color ORANGE Score 1
Shape OVAL Size 20 mm
Imprint Code VVV;CS

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Reckitt Benckiser LLC( 094405024)

Principal display panel - 20 caplet blister pack carton

MAXIMUM STRENGTH*
NDC 63824-236-20

Mucinex®
FAST-MAX ®

CONGESTION &
HEADACHE

AcetaminophenPain Reliever/Fever Reducer
Guaifenesin Expectorant
Phenylephrine HCl Nasal Decongestant

Relieves Headache & Fever
Relieves Nasal & Chest Congestion
Thins & Loosens Mucus

20 CAPLETS
FOR AGES 12+