OTC Medication Information: Mucinex Sinus-Max Pressure and Pain

MUCINEX SINUS-MAX PRESSURE AND PAIN — acetaminophen, guaifenesin, and 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.

Drug Facts

Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • 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 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

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 are taking 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 rash or persistent headache. 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 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

croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Questions?

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

Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
Made in England

PRINCIPAL DISPLAY PANEL — 10 Tablet Blister Carton

MAXIMUM STRENGTH*
NDC 63824-203-22

Mucinex® SINUS — MAX™

Pressure & Pain

Acetaminophen — Pain Reliever • Guaifenesin — Expectorant
Phenylephrine HCl — Nasal Decongestant

Relieves Sinus Pressure & Congestion
Relieves Headache
Thins & Loosens Mucus

ONE 20 caplet pack + ONE 30 caplet pack

For Ages 12+

TOTAL 50 CAPLETS

Principal Display Panel -- 10 Tablet Blister Carton
(click image for full-size original)
MUCINEX SINUS-MAX PRESSURE AND PAIN
acetaminophen, guaifenesin, and phenylephrine hydrochloride kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-203
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63824-203-22 1 KIT in 1 CELLO PACK None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 BLISTER PACK 20
Part 2 3 BLISTER PACK 30
Part 1 of 2
MUCINEX SINUS-MAX PRESSURE AND PAIN
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated
Product Information
Item Code (Source) NDC:63824-200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 325 mg
Guaifenesin (Guaifenesin) Guaifenesin 200 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
CROSPOVIDONE (120 .MU.M)
D&C yellow no. 10
FD&C yellow no. 6
aluminum oxide
magnesium stearate
microcrystalline cellulose
polyethylene glycol, unspecified
polyvinyl alcohol, unspecified
povidone, unspecified
talc
titanium dioxide
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 20mm
Flavor Imprint Code VVV;SP
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63824-200-20 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (63824-200-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/23/2012
Part 2 of 2
MUCINEX SINUS-MAX PRESSURE AND PAIN
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated
Product Information
Item Code (Source) NDC:63824-200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 325 mg
Guaifenesin (Guaifenesin) Guaifenesin 200 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
CROSPOVIDONE (120 .MU.M)
D&C yellow no. 10
FD&C yellow no. 6
aluminum oxide
magnesium stearate
microcrystalline cellulose
polyethylene glycol, unspecified
polyvinyl alcohol, unspecified
povidone, unspecified
talc
titanium dioxide
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 20mm
Flavor Imprint Code VVV;SP
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63824-200-30 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (63824-200-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/23/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/15/2013
Labeler — RB Health (US) LLC (081049410)

Revised: 01/2022 RB Health (US) LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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