Mucinex® Sinus-max®

Mucinex® Sinus-max®
SPL v4
SPL
SPL Set ID 1e243dbe-138f-4346-ba22-ceea01e97052
Route
ORAL
Published
Effective Date 2021-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Lecithin, Soybean Mineral Oil Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Shellac Sorbitol Titanium Dioxide Water

Identifiers & Packaging

Pill Appearance
Imprint: PC9 Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-07-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
    • cough
  • temporarily promotes nasal and/or sinus drainage
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not use more than directed

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

Section 53414-9

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

Section 55105-1
Active ingredients (in each liquid gel) Purposes
Acetaminophen 325 mg Pain reliever
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
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
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.
Questions?

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

You may also report side effects to this phone number.

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.

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
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.

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

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, water

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.
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, or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 16 Capsule Blister Pack Carton

Fast Dissolving Liquid Gels!

MAXIMUM STRENGTH

NDC 63824-692-16

Mucinex®

SINUS-
MAX®

SEVERE CONGESTION

& PAIN

Acetaminophen –Pain Reliever

Dextromethorphan HBr - Cough Suppressant

Phenylephrine HCl – Nasal Decongestant

✓Clears Sinus Congestion

✓Relieves Headache

✓Controls Cough

16

LIQUID GELS

(Liquid Filled Capsules)

DAY TIME

FOR AGES 12+


Structured Label Content

Uses
  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
    • cough
  • temporarily promotes nasal and/or sinus drainage
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each liquid gel) Purposes
Acetaminophen 325 mg Pain reliever
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
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
Do Not Use (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.
Questions?

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

You may also report side effects to this phone number.

Allergy Alert (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.

Liver Warning (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
Overdose Warning (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.

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • avoid excessive heat
Inactive Ingredients (Inactive ingredients)

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, water

Stop Use and Ask A Doctor If (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.
Ask A Doctor Before Use If You Have (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, or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 16 Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 16 Capsule Blister Pack Carton)

Fast Dissolving Liquid Gels!

MAXIMUM STRENGTH

NDC 63824-692-16

Mucinex®

SINUS-
MAX®

SEVERE CONGESTION

& PAIN

Acetaminophen –Pain Reliever

Dextromethorphan HBr - Cough Suppressant

Phenylephrine HCl – Nasal Decongestant

✓Clears Sinus Congestion

✓Relieves Headache

✓Controls Cough

16

LIQUID GELS

(Liquid Filled Capsules)

DAY TIME

FOR AGES 12+


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)