MUCINEX SINUS - MAX DAY / NIGHT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride 
RB Health (US) 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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Mucinex® Sinus-Max®
DAY & NIGHT

Drug Facts

Active ingredients (in each liquid gel)
Mucinex SINUS-MAX DAY
Purposes
Acetaminophen 325 mgPain reliever
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
Active ingredients (in each liquid gel)
Mucinex SINUS-MAX NIGHT
Purposes
Acetaminophen 325 mgPain reliever
Dextromethorphan HBr 10 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

  • temporarily relieves:
    • nasal congestion
    • headache
    • cough
    • minor aches and pains
    • sinus congestion and pressure
    • runny nose and sneezing (NIGHT only)
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)

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.

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)
  • breathing problems 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 older: 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, shellac, sorbitol sorbitan solution, titanium dioxide, water

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, shellac, sorbitol sorbitan solution, titanium dioxide, water

Questions?

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

You may also report side effects to this phone number.

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

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 63824-690-48

48
LIQUID GELS

Fast Dissolving Liquid Gels!

MAXIMUM STRENGTH

Mucinex®
SINUS-MAX®

DAY

Acetaminophen – Pain Reliever
Dextromethorphan HBr - Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

  • Relieves Sinus Pressure, Headache
    & Congestion
  • Controls Cough
  • Thins & Loosens Mucus

32
LIQUID GELS
(Liquid Filled
Capsules)

NIGHT

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

  • Relieves Nasal Congestion,
    Sinus Pressure & Pain
  • Controls Cough
  • Relieves Runny Nose & Sneezing

48TOTAL
AGES 12+

16
LIQUID GELS
(Liquid Filled
Capsules)

PRINCIPAL DISPLAY PANEL - Kit Carton
MUCINEX SINUS - MAX  DAY / NIGHT
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-690
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-690-481 in 1 CARTON07/15/201512/31/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 BLISTER PACK 32 
Part 22 BLISTER PACK 16 
Part 1 of 2
MUCINEX SINUS-MAX   DAY
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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)  
SHELLAC (UNII: 46N107B71O)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize26mm
FlavorImprint Code PC26
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 CARTON
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/2015
Part 2 of 2
MUCINEX SINUS-MAX   NIGHT
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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)  
SHELLAC (UNII: 46N107B71O)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize20mm
FlavorImprint Code PC22
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 CARTON
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/201512/31/2021
Labeler - RB Health (US) LLC (081049410)

Revised: 7/2023
 
RB Health (US) LLC