MUCINEX FAST-MAX COLD, FLU AND SORE THROAT - guaifenesin, phenylephrine hydrochloride, acetaminophen and dextromethorphan hydrobromide tablet, coated
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 caplet)	Purpose
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
cough
minor aches and pains
sore throat
headache
temporarily reduces fever
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

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.
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)

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 (1-800-222-1222). 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 outer package is opened or blister is torn or broken
store at 15-30°C (59-86°F)

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C blue #1 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.

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

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack

MAXIMUM STRENGTH*

NDC 63824-191-20

Mucinex®

FAST-MAX™

Cold, Flu & Sore Throat

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

NEW!

✓: Relieves Headache, Fever & Sore Throat
✓: Controls Cough
✓: Relieves Nasal & Chest Congestion
✓: Thins & Loosens Mucus

For Ages 12+

20 CAPLETS

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack

MUCINEX FAST-MAX COLD, FLU AND SORE THROAT
guaifenesin, phenylephrine hydrochloride, acetaminophen, and dextromethorphan hydrobromide tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-191
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (Guaifenesin)	Guaifenesin	200 mg
Phenylephrine Hydrochloride (Phenylephrine)	Phenylephrine Hydrochloride	5 mg
Acetaminophen (Acetaminophen)	Acetaminophen	325 mg
Dextromethorphan hydrobromide (Dextromethorphan)	Dextromethorphan hydrobromide	10 mg

Inactive Ingredients
Ingredient Name	Strength
croscarmellose sodium
crospovidone
FD&C blue no. 1
aluminum oxide
magnesium stearate
cellulose, microcrystalline
polyethylene glycols
polyvinyl alcohol
povidone
talc
titanium dioxide

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	30mm
Flavor		Imprint Code	VVV;CFS
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:63824-191-20	1 BLISTER PACK in 1 CARTON	contains a BLISTER PACK
1		20 TABLET, COATED in 1 BLISTER PACK	This package is contained within the CARTON (63824-191-20)
2	NDC:63824-191-30	1 BLISTER PACK in 1 CARTON	contains a BLISTER PACK
2		30 TABLET, COATED in 1 BLISTER PACK	This package is contained within the CARTON (63824-191-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/01/2012

Labeler - Reckitt Benckiser LLC (094405024)

Revised: 06/2012 Reckitt Benckiser LLC