Assured™ Maximum Strength Mucus Relief

SPL v1

SPL

SPL Set ID 0d811f94-16b1-4ba8-aeea-6f947b69ba24

Route

ORAL

Published

Effective Date 2016-08-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 341 Shape: oval Color: orange Size: 21 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2016-08-12

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- cough
- minor aches and pains
- sore throat
temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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 softgel)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
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.

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 between 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 yellow no. 6, FD&C red no.40, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, purified water

Questions Or Comments?

Call 1-888-333-9792

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 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, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)

Principal Display Panel 10 Softgel Blister Pack Carton

COMPARE TO ACTIVE INGREDIENTS IN

MUCINEX^® FAST-MAX^® COLD, FLU & SORE THROAT*

ASSURED™

MAXIMUM STRENGTH

Mucus Relief

Acetaminophen 325 mg
- -
  Pain Reliever / Fever Reducer
Dextromethorphan HBr 10 mg - Cough Suppressant
Guaifenesin 200 mg - Expectorant
Phenylephrine HCl 5 mg - Nasal Decongestant

Thins & Loosens Mucus,

Nasal Congestion,

Coughing, Fever & Headache

Non-Drowsy

Actual Size

AGES 12+

10 softgels

Structured Label Content

Uses

temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- cough
- minor aches and pains
- sore throat
temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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 softgel)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
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.

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)

Other Information (Other information)

store between 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 yellow no. 6, FD&C red no.40, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, purified water

Questions Or Comments? (Questions or Comments?)

Call 1-888-333-9792

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 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, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)

Principal Display Panel 10 Softgel Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton)

COMPARE TO ACTIVE INGREDIENTS IN

MUCINEX^® FAST-MAX^® COLD, FLU & SORE THROAT*

ASSURED™

MAXIMUM STRENGTH

Mucus Relief

Acetaminophen 325 mg
- -
  Pain Reliever / Fever Reducer
Dextromethorphan HBr 10 mg - Cough Suppressant
Guaifenesin 200 mg - Expectorant
Phenylephrine HCl 5 mg - Nasal Decongestant

Thins & Loosens Mucus,

Nasal Congestion,

Coughing, Fever & Headache

Non-Drowsy

Actual Size

AGES 12+

10 softgels

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold and flu symptoms: nasal congestion headache cough minor aches and pains sore throat temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product, do not use more than directed.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant 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.", "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 between 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 yellow no. 6, FD&C red no.40, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, purified water", "Questions or Comments?": "Call 1-888-333-9792", "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 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, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)", "PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton": "COMPARE TO ACTIVE INGREDIENTS IN MUCINEX ® FAST-MAX ® COLD, FLU & SORE THROAT* ASSURED ™ MAXIMUM STRENGTH Mucus Relief Acetaminophen 325 mg - Pain Reliever / Fever Reducer Dextromethorphan HBr 10 mg - Cough Suppressant Guaifenesin 200 mg - Expectorant Phenylephrine HCl 5 mg - Nasal Decongestant Thins & Loosens Mucus, Nasal Congestion, Coughing, Fever & Headache Non-Drowsy Actual Size AGES 12+ 10 softgels"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:09.205179 · Updated: 2026-03-14T22:54:23.335310