MAXIMUM STRENGTH MUCINEX FAST-MAX DAY COLD AND FLU AND NIGHT COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, and phenylephrine hydrochloride kit

Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu by

Drug Labeling and Warnings

Maximum Strength Mucinex Fast-Max Day Cold and Flu and 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 liquid gel)	Purposes
Mucinex FAST-MAX DAY Cold & Flu
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

ACTIVE INGREDIENT

Active ingredients (in each liquid gel)	Purposes
Mucinex FAST-MAX NIGHT Cold & Flu
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Doxylamine succinate 6.25 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • sinus congestion and pressure
  • cough
  • minor aches and pains
  • headache
  • nasal congestion
  • sore throat
  • runny nose (NIGHT only)
  • sneezing (NIGHT only)
  • itching of the nose or throat (NIGHT only)
  • itchy, watery eyes due to hay fever (NIGHT only)
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
• controls cough to help you get to sleep
• temporarily reduces fever

Warnings

Liver warning

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

• more than 12 liquid gels 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.

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
• glaucoma (NIGHT only)
• a breathing problem such as emphysema or chronic bronchitis (NIGHT 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
• taking sedatives or tranquilizers (NIGHT only)

When using this product

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

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 fever, rash, or headache that lasts. 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 any signs or symptoms.

Directions

• do not take more than directed (see Overdose warning)
• do not take more than 12 liquid gels in any 24-hour period
• adults and children 12 years of age and over: take 2 liquid gels every 4 hours
• children under 12 years of age: do not use

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat

Inactive ingredients (DAY only)

FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Inactive ingredients (NIGHT only)

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, 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

Made in China

PRINCIPAL DISPLAY PANEL - Kit Carton

Fast Dissolving Liquid Gels!

MAXIMUM STRENGTH
NDC: 63824-519-24

Mucinex®
FAST-MAX®

DAY
COLD & FLU

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

HEADACHE
BODY PAIN

SORE THROAT
FEVER

CHEST CONGESTION
COUGH

ALL IN
ONE*

NASAL CONGESTION
SINUS CONGESTION

SINUS PRESSURE

16

LIQUID GELS
(Liquid Filled
Capsules)

NIGHT
COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Doxylamine succinate - Antihistamine
Phenylephrine HCl – Nasal Decongestant

HEADACHE
BODY PAIN

SORE THROAT
FEVER

ITCHY THROAT
COUGH

ALL IN
ONE*

NASAL CONGESTION
SNEEZING

RUNNY NOSE

8

LIQUID GELS
(Liquid Filled
Capsules)

24 TOTAL
AGES 12+

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH MUCINEX FAST-MAX DAY COLD AND FLU AND NIGHT COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, and phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-519

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-519-24	1 in 1 CARTON	07/28/2018
1		1 in 1 KIT
2	NDC: 63824-519-48	2 in 1 CARTON	07/28/2018
2		1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BLISTER PACK	16
Part 2	1 BLISTER PACK	8

Part 1 of 2

MAXIMUM STRENGTH MUCINEX FAST-MAX DAY COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
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
FD&C yellow no. 6 (UNII: H77VEI93A8)
gelatin, unspecified (UNII: 2G86QN327L)
glycerin (UNII: PDC6A3C0OX)
lecithin, soybean (UNII: 1DI56QDM62)
mineral oil (UNII: T5L8T28FGP)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
povidone, unspecified (UNII: FZ989GH94E)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
shellac (UNII: 46N107B71O)
titanium dioxide (UNII: 15FIX9V2JP)
sorbitan (UNII: 6O92ICV9RU)
sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	24mm
Flavor		Imprint Code	PC26
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 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	07/28/2018

Part 2 of 2

MAXIMUM STRENGTH MUCINEX FAST-MAX NIGHT COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg
Doxylamine Succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL)	Doxylamine Succinate	6.25 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg

Inactive Ingredients
Ingredient Name	Strength
D&C yellow no. 10 (UNII: 35SW5USQ3G)
FD&C blue no. 1 (UNII: H3R47K3TBD)
gelatin, unspecified (UNII: 2G86QN327L)
glycerin (UNII: PDC6A3C0OX)
lecithin, soybean (UNII: 1DI56QDM62)
mineral oil (UNII: T5L8T28FGP)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
povidone, unspecified (UNII: FZ989GH94E)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
shellac (UNII: 46N107B71O)
titanium dioxide (UNII: 15FIX9V2JP)
sorbitan (UNII: 6O92ICV9RU)
sorbitol (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 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	07/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/28/2018

Labeler - RB Health (US) LLC (081049410)