Mucinex® Sinus-Max® Pressure, Pain & Cough and Mucinex® Sinus-Max® Severe Nasal Congestion Relief Clear & Cool Nasal Spray

Mucinex Sinus-Max Pressure, Pain and Cough and Mucinex Sinus-Max Severe Congestion Relief Clear and Cool by

Drug Labeling and Warnings

Mucinex Sinus-Max Pressure, Pain and Cough and Mucinex Sinus-Max Severe Congestion Relief Clear and Cool by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH AND MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF CLEAR AND COOL- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride and oxymetazoline hydrochloride 
RB Health (US) LLC

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Mucinex® Sinus-Max® Pressure, Pain & Cough and Mucinex® Sinus-Max® Severe Nasal Congestion Relief Clear & Cool Nasal Spray

Mucinex Sinus-Max Pressure, Pain & Cough

Drug Facts

Active ingredients (in each liquid gel)Purposes
Acetaminophen 325 mgPain reliever
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • cough
    • sinus congestion and pressure
  • 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

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
  • 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 aretaking 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 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

FD&C yellow no. 6, 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

Mucinex Sinus-Max Severe Nasal Congestion Relief

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to:
    • a cold
    • hay fever or other upper respiratory allergies
  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen membranes

Warnings

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

When using this product

  • do not exceed recommended dosage
  • do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
  • the use of this container by more than one person may spread infection

Stop use and ask a doctor ifsymptoms persist

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

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: consult a doctor.

Shake well before use.

To open, hold by the white grips then squeeze and turn cap. Before using for the first time, remove the protective cap from the tip and prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at the base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use. To close, turn cap until it "clicks".

DO NOT DISCARD CAP

Other information

  • store at 20-25°C (68-77°F)

Inactive ingredients

benzalkonium chloride, camphor, edetate disodium, eucalyptol, glycine, menthol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium chloride, sodium hydroxide

Questions?

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

You may also report side effects to this number.

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

PRINCIPAL DISPLAY PANEL - Kit Carton

VALUE PACK! 2 formats in 1 (Nasal Spray & Liquid Gels)

Mucinex®

SINUS-MAX®

SEVERE

NASAL CONGESTION

RELIEF

CLEAR & COOL

NASAL SPRAY

Oxymetazoline HCl 0.05%

Nasal Decongestant

  • Fast acting
  • Lasts 12 Hours
  • Cooling Menthol

    flavor

FOR AGES 6+

MAXIMUM STRENGTH

NDC: 63824-509-02

Mucinex®

SINUS-MAX®

PRESSURE, PAIN

& COUGH

Acetaminophen – Pain Reliever

Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant Phenylephrine HCl – Nasal Decongestant

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

Actual Size

FOR AGES 12+

3/4 FL OZ (22 mL) + 16 LIQUID GELS

(Liquid Filled Capsules)

Label

MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH AND MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF CLEAR AND COOL 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride and oxymetazoline hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63824-509
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63824-509-021 in 1 CARTON08/01/202004/15/2024
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 16 
Part 21 BOTTLE, PUMP 22 mL
Part 1 of 2
MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and 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
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 DrugM01207/01/2017
Part 2 of 2
MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF CLEAR AND COOL 
oxymetazoline hydrochloride solution
Product Information
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EUCALYPTOL (UNII: RV6J6604TK)  
GLYCINE (UNII: TE7660XO1C)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
122 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01208/01/202004/15/2024
Labeler - RB Health (US) LLC (081049410)

Revised: 10/2023
 

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