Maximum Strength Nighttime Cold And Flu 6 Fl Oz. (180 Ml)

Maximum Strength Nighttime Cold And Flu 6 Fl Oz. (180 Ml)
SPL v7
SPL
SPL Set ID 058b2021-8a61-40b0-8a2e-a784d2b847fb
Route
ORAL
Published
Effective Date 2020-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Diphenhydramine (25 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Potassium Citrate Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-04

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
  • temporarily reduces fever
  • controls cough to help you get to sleep
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Section 55105-1
Active ingredients (in each 20 mL) Purposes

Acetaminophen 650 mg

Pain reliever/fever reducer

Diphenhydramine HCl 25 mg

Antihistamine/cough suppressant

Phenylephrine HCl 10 mg

Nasal decongestant

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL= milliliter
  • adults and children 12 years of age and older:20 mL in dosing cup provided 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.
  • with any other drug containing diphenhydramine, even one used on the skin
  • 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.
Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 doses 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.

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.

Other Information
  • each 20 mL contains:sodium 6 mg
  • low sodium
  • store at room temperature
  • do not refrigerate
  • dosing cup provided
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.

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, natural and artificial flavor, potassium citrate ,propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions Or Comments?

1-888-287-1915

When Using This Product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks

be careful when driving a motor vehicle or operating machinery

Principal Display Panel

NDC# 30142-736-06

Compare to Mucinex ®Fast-Max ®Maximum Strength Might Time Cold & Flu Active Ingredients

Maximum Strength

Night Time Cold & Flu

  • AcetaminophenPain Reliever/Fever Reducer

    Diphenhydramine HCl Antihistamine/Cough Suppressant

    Phenylephrine HCl Nasal Decongestant
  • Relieves:
  • Sore Throat; Itchy Throat-Cough
  • Nasal Congestion – Sneezing & Runny Nose
  • Headache – Body Pain

For Ages 12+

6 FL OZ (180 mL)

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex ®Fast- Max ®Maximum Strength Nighttime Cold & Flu

Tamper evident: do not use if printed seal under cap is broken or missing.

‡Maximum Strength per 4 hour dose.

Distributed by:

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
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
  • temporarily reduces fever
  • controls cough to help you get to sleep
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 20 mL) Purposes

Acetaminophen 650 mg

Pain reliever/fever reducer

Diphenhydramine HCl 25 mg

Antihistamine/cough suppressant

Phenylephrine HCl 10 mg

Nasal decongestant

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL= milliliter
  • adults and children 12 years of age and older:20 mL in dosing cup provided 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.
  • with any other drug containing diphenhydramine, even one used on the skin
  • 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.
Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 doses 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.

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.

Other Information (Other information)
  • each 20 mL contains:sodium 6 mg
  • low sodium
  • store at room temperature
  • do not refrigerate
  • dosing cup provided
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 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.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, natural and artificial flavor, potassium citrate ,propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions Or Comments? (Questions or comments?)

1-888-287-1915

When Using This Product (When using this product)
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks

be careful when driving a motor vehicle or operating machinery

Principal Display Panel (PRINCIPAL DISPLAY PANEL -)

NDC# 30142-736-06

Compare to Mucinex ®Fast-Max ®Maximum Strength Might Time Cold & Flu Active Ingredients

Maximum Strength

Night Time Cold & Flu

  • AcetaminophenPain Reliever/Fever Reducer

    Diphenhydramine HCl Antihistamine/Cough Suppressant

    Phenylephrine HCl Nasal Decongestant
  • Relieves:
  • Sore Throat; Itchy Throat-Cough
  • Nasal Congestion – Sneezing & Runny Nose
  • Headache – Body Pain

For Ages 12+

6 FL OZ (180 mL)

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex ®Fast- Max ®Maximum Strength Nighttime Cold & Flu

Tamper evident: do not use if printed seal under cap is broken or missing.

‡Maximum Strength per 4 hour dose.

Distributed by:

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
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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 (Ask a doctor or pharmacist before use if)
  • you are taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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