Maximum Strength Nighttime Cold And Flu
FDA Label NDC 49035-933

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores,inc., for the product Maximum Strength Nighttime Cold And Flu (NDC 49035-933). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Otc - Purpose

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

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

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.

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.
  • for children under 12 years of age

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
  • you are taking sedatives or tranquilizers

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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.

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 8 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

Questions Or Comments?

1-866-467-2748

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Compare to Mucinex® Fast-Max® Maximum Strength Severe Cold & Flu Active Ingredients *

Maximum Strength‡

Night Time
Cold & Flu

  •  Acetaminophen Pain Reliever/Fever Reducer
    Diphenhydramine HCl Antihistamine/Cough Suppressant
    Phenylephrine HCl Nasal Deongestant
    • Relieves Ache, Fever and Sore Throat
    • Controls Cough
    • Relieves Nasal Congestion
    • Relieves Runny Nose & Sneezing
    • 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 Severe Cold & flu.

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

      ‡Maximum Strength per 4 hour dose.

      Distributed by: Walmart Inc.,

      Bentonville, AR 72716

      Equate Maximum Strength Nighttime Cold & Flu 6 Fl Oz (Mucinex 01)

      Equate Maximum Strength Nighttime Cold & Flu 6 Fl Oz (Mucinex 01)

* Please review the disclaimer below.