MUCINEX FAST-MAX NIGHT TIME COLD AND FLU- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated

Mucinex Fast-Max by

Drug Labeling and Warnings

Mucinex Fast-Max by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Diphenhydramine HCl 25 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • headache
  • minor aches and pains
  • sore throat
  • runny nose and sneezing
• temporarily reduces fever

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.
• with any other drug containing diphenhydramine, even one used on the skin
• 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
• diabetes
• high blood pressure
• thyroid disease
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain or nasal congestion 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

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 of age and older: take 2 caplets every 4 hours
• children under 12 years of age: do not use

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

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

PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

MAXIMUM STRENGTH*
NDC: 63824-550-20

Mucinex®

FAST-MAX®

NIGHT TIME
Cold & Flu

Acetaminophen Pain Reliever/Fever Reducer
Diphenhydramine HCl Antihistamine
Phenylephrine HCl Nasal Decongestant

NEW!

• ✓ Relieves Aches, Fever & Sore Throat
• ✓ Relieves Nasal Congestion
• ✓ Relieves Runny Nose & Sneezing

For Ages 12+
20 CAPLETS

INGREDIENTS AND APPEARANCE

MUCINEX FAST-MAX   NIGHT TIME COLD AND FLU
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-550
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	25 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg

Inactive Ingredients
Ingredient Name	Strength
starch, corn (UNII: O8232NY3SJ)
croscarmellose sodium (UNII: M28OL1HH48)
crospovidone (UNII: 68401960MK)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
hypromelloses (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
cellulose, microcrystalline (UNII: OP1R32D61U)
polydextrose (UNII: VH2XOU12IE)
polyethylene glycols (UNII: 3WJQ0SDW1A)
povidones (UNII: FZ989GH94E)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
titanium dioxide (UNII: 15FIX9V2JP)
triacetin (UNII: XHX3C3X673)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	44;544
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-550-20	2 in 1 CARTON
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/30/2013

Labeler - Reckitt Benckiser LLC (094405024)