Mucinex® Fast-Max™ Cold, Flu & Sore Throat

MUCINEX FAST-MAX  COLD, FLU AND SORE THROAT - acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride liquid 
Reckitt Benckiser LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients
(in each 20 mL)
Purpose
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal decongestant

Uses

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

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
  • 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 and signs or symptoms.

Directions

Other information

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum


1
may contain this ingredient

Questions?

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

You may also report side effects to this phone number.

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

PRINCIPAL DISPLAY PANEL - 266 mL Bottle Label

MAXIMUM STRENGTH*
NDC 63824-015-69

Mucinex®
FAST-MAX™

Cold, Flu &
Sore Throat

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

NEW
VALUE SIZE!

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

9 fl oz (266 mL)
For Ages 12+

Principal Display Panel - 266 mL Bottle Label

MUCINEX FAST-MAX   COLD, FLU AND SORE THROAT
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-015
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen650 mg  in 20 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide20 mg  in 20 mL
Guaifenesin (Guaifenesin) Guaifenesin400 mg  in 20 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
Anhydrous Citric Acid 
Edetate Disodium 
FD&C Blue No. 1 
FD&C Red No. 40 
Glycerin 
Propylene Glycol 
Propyl Gallate 
Water 
Sodium Benzoate 
Sorbitol 
Sucralose 
Trisodium Citrate Dihydrate 
Xanthan Gum 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:63824-015-691 BOTTLE in 1 CARTONcontains a BOTTLE
1266 mL in 1 BOTTLEThis package is contained within the CARTON (63824-015-69)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/15/201206/21/2012

Labeler - Reckitt Benckiser LLC (094405024)

Revised: 06/2012 Reckitt Benckiser LLC