Mucinex® Rapid Clear® Liquid Gels Pain, Headache & Cough

Mucinex® Rapid Clear® Liquid Gels Pain, Headache & Cough
SPL v5
SPL
SPL Set ID 37de53a7-5546-3804-e063-6294a90a0fb5
Route
ORAL
Published
Effective Date 2021-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Sorbitol Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Hypromellose, Unspecified Isopropyl Alcohol Light Mineral Oil Polyethylene Glycol, Unspecified Water Povidone, Unspecified Propylene Glycol Titanium Dioxide 1,4-sorbitan Lecithin, Sunflower Mannitol

Identifiers & Packaging

Pill Appearance
Imprint: AR18 Shape: oval Color: red Size: 24 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporarily relieves these common cold and flu symptoms:

■ cough due to minor throat and bronchial irritation as

may occur with the common cold or inhaled irritants

■ the intensity of coughing

■ the impulse to cough to help you get to sleep

■ minor aches and pains

■ sore throat

■ headache

■ temporarily reduces fever

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 are taking 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/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Section 55106-9

Active ingredients (in each liquid gel) Purposes

Acetaminophen 325 mg Pain reliever/fever reducer

Dextromethorphan HBr 10 mg Cough suppressant

Warnings

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

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
Do Not Use
  • with any other drug containing acetaminophen (precription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a precription 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 precription 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
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.

Inactive Ingredients

FD&C red no. 40, FD&C yellow

no. 6, gelatin, glycerin, hypromellose, isopropyl alcohol,

lecithin (sunflower), light mineral oil, mannitol, polyethylene

glycol 400, povidone, propylene glycol, purified water,

1,4-sorbitan, sorbitol, titanium dioxide

Stop Use and Ask A Doctor If

■ pain 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 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
  • persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 16 Capsule Blister Pack Carton

Fast Dissolving Liquid Gels!

NDC 72854-214

MAXIMUM STRENGTH

MUCINEX®



Acetaminophen – Pain Reliever/Fever Reducer



Dextromethorphan HBr – Cough Suppressant

LIQUID GELS



(Liquid Filled Capsules)

Actual Size

FOR AGES 12 +


Structured Label Content

Uses

temporarily relieves these common cold and flu symptoms:

■ cough due to minor throat and bronchial irritation as

may occur with the common cold or inhaled irritants

■ the intensity of coughing

■ the impulse to cough to help you get to sleep

■ minor aches and pains

■ sore throat

■ headache

■ temporarily reduces fever

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 are taking 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/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Section 55106-9 (55106-9)

Active ingredients (in each liquid gel) Purposes

Acetaminophen 325 mg Pain reliever/fever reducer

Dextromethorphan HBr 10 mg Cough suppressant

Warnings

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

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
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (precription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a precription 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 precription 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
Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

FD&C red no. 40, FD&C yellow

no. 6, gelatin, glycerin, hypromellose, isopropyl alcohol,

lecithin (sunflower), light mineral oil, mannitol, polyethylene

glycol 400, povidone, propylene glycol, purified water,

1,4-sorbitan, sorbitol, titanium dioxide

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ pain 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 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
  • persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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!

NDC 72854-214

MAXIMUM STRENGTH

MUCINEX®



Acetaminophen – Pain Reliever/Fever Reducer



Dextromethorphan HBr – Cough Suppressant

LIQUID GELS



(Liquid Filled Capsules)

Actual Size

FOR AGES 12 +


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)