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

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

Description

Drug Facts

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:

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

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.

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.

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

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

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:

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

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.

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.

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

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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