MUCINEX FAST-MAX DAY SEVERE CONGESTION AND COUGH AND MUCINEX NIGHTSHIFT NIGHT COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit

Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu by

Drug Labeling and Warnings

Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet) Mucinex Fast-Max Day Severe Congestion & Cough	Purposes
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Active ingredients (in each caplet) Mucinex Nightshift Night Cold & Flu	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Triprolidine HCl 1.25 mg	Antihistamine

Uses

Mucinex Fast-Max Day Severe Congestion & Cough

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the impulse to cough to help you get to sleep
  • the intensity of coughing
  • nasal congestion due to a cold

Mucinex Nightshift Night Cold & Flu

• temporarily relieves these common cold and flu symptoms:
  • cough
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever
• temporarily reduces fever
• controls cough to help you get to sleep

Warnings

Liver warning (Nightshift Night Cold & Flu only)

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg 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 (Nightshift Night Cold & Flu only)

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.

Sore throat warning (Nightshift Night Cold & Flu only)

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. (Nightshift Night Cold & Flu only)
• 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 (Nightshift Night Cold & Flu only)
• heart disease (Fast-Max Day Severe Congestion & Cough only)
• high blood pressure (Fast-Max Day Severe Congestion & Cough only)
• thyroid disease (Fast-Max Day Severe Congestion & Cough only)
• diabetes (Fast-Max Day Severe Congestion & Cough only)
• glaucoma (Nightshift Night Cold & Flu only)
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis (Nightshift Night Cold & Flu only)
• 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 (Nightshift Night Cold & Flu only)
• taking sedatives or tranquilizers (Nightshift Night Cold & Flu only)

When using this product

• do not use more than directed
• excitability may occur, especially in children (Nightshift Night Cold & Flu only)
• marked drowsiness may occur (Nightshift Night Cold & Flu only)
• alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Night Cold & Flu only)
• avoid alcoholic drinks (Nightshift Night Cold & Flu only)
• use caution when driving a motor vehicle or operating machinery (Nightshift Night Cold & Flu only)

Stop use and ask a doctor if

• pain or cough gets worse or lasts more than 7 days (Nightshift Night Cold & Flu only)
• fever gets worse or lasts more than 3 days (Nightshift Night Cold & Flu only)
• redness or swelling is present (Nightshift Night Cold & Flu only)
• new symptoms occur (Nightshift Night Cold & Flu only)
• cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Nightshift Night Cold & Flu only)
• nervousness, dizziness, or sleeplessness occur (Fast-Max Day Severe Congestion & Cough only)
• symptoms do not get better within 7 days or occur with fever (Fast-Max Day Severe Congestion & Cough only)
• cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Fast-Max Day Severe Congestion & Cough only)

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Overdose warning (Nightshift Night Cold & Flu only)

Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Mucinex Fast-Max Day Severe Congestion & Cough

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

Mucinex Nightshift Night Cold & Flu

• do not take more than directed (see Overdose warning)
• do not take more than 8 caplets in any 24-hour period
• adults and children 12 years of age and over: 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 Mucinex Fast-Max Day Severe Congestion & Cough

croscarmellose sodium, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, methacrylic acid-ethyl acrylate copolymer, mica, microcrystalline cellulose, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide

Inactive ingredients Mucinex Nightshift Night Cold & Flu

croscarmellose sodium, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, titanium dioxide

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

FAST RELEASE. POWERFUL SYMPTOM RELIEF!

NDC: 72854-242-40

MAXIMUM STRENGTH
Mucinex®
FAST-MAX ® NIGHTSHIFT

DAY
SEVERE CONGESTION
& COUGH

Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

• Controls Cough
• Relieves Nasal & Chest
  Congestion
• Thins & Loosens Mucus

ACTUAL SIZE

FOR AGES 12+

24 CAPLETS

NIGHT
COLD & FLU

Acetaminophen – Pain Reliever/
Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Triprolidine HCl – Antihistamine

NIGHTTIME
RELIEF FOR A BETTER
MORNING

✓COUGH ✓FEVER ✓SORE THROAT
✓RUNNY NOSE ✓SNEEZING

ACTUAL SIZE

FOR AGES 12+

16 CAPLETS

FAST
RELEASE

TOTAL 40 CAPLETS

INGREDIENTS AND APPEARANCE

MUCINEX FAST-MAX DAY SEVERE CONGESTION AND COUGH AND MUCINEX NIGHTSHIFT NIGHT COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-242

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-242-40	1 in 1 CARTON	07/01/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 BLISTER PACK	24
Part 2	4 BLISTER PACK	16

Part 1 of 2

MUCINEX FAST-MAX  SEVERE CONGESTION AND COUGH
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, coated

Product Information
Item Code (Source)	NDC: 63824-193
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	VVV;SCC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 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 Drug	M012	07/01/2021

Part 2 of 2

MUCINEX NIGHTSHIFT COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, and triprolidine hydrochloride tablet, coated

Product Information
Item Code (Source)	NDC: 72854-233
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	1.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	VVV;LOGOcrescentmoon
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 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 Drug	M012	07/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/01/2021

Labeler - RB Health (US) LLC (081049410)