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Nighttime Cold and Flu Maximum Strength

Dosage form: liquid
Ingredients: ACETAMINOPHEN 650mg in 20mL, DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 20mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 20mL
Labeler: Walgreens
NDC Code: 0363-0460

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg 

Phenylephrine HCI 10 mg 

Purpose

Pain reliever/fever reducer

Antihistamine / cough suppressant

Nasal decongestant

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

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • 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
  • 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
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • 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 rash, or headache that lasts These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 hours period
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product 
  • mL = milliliter
  • dose as follows or as directed by a doctor 
  • adults and children 12 years and older :
    • 20 mL every 4 hours while symptoms last
  • children under 12 years of age do not use

Other information
  • each 20 mL contains: sodium 12 mg
  • store between 20-25ºC (68-77F). Do not refrigerate

Inactive ingredients

citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu active ingredients††

NIGHTTIME

Cold & Flu

ACETAMINOPHEN / PAIN RELIEVER & FEVER REDUCER

DIPHENHYDRAMINE HCI / ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCI / NASAL DECONGESTANT

MAXIMUM STRENGTH

  • Relieves aches, fever & sore throat, nasal congestion, runny nose & sneezing
  • Controls cough
  • For ages 12 & over

FL OZ (mL)

††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu 

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY : WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Product Label

WALGREENS Nighttime Cold & Flu Maximum Strength

NIGHTTIME COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, diphenhydramine hci, phenylephrine hci liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0460
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 20 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
PROPYL GALLATE 
SODIUM BENZOATE 
SODIUM CITRATE 
SUCRALOSE 
XANTHAN GUM 
EDETATE CALCIUM DISODIUM 
Packaging
#Item CodePackage Description
1NDC:0363-0460-06177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/2015
Labeler - Walgreens (008965063)

 
Walgreens

← See all Nighttime Cold and Flu Maximum Strength brands

Medically reviewed on Nov 6, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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