FDA Label for Walgreens Nighttime Cold And Flu

View Indications, Usage & Precautions

Walgreens Nighttime Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



Active ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan Hydrobromide 15 mgCough suppressant
Doxylamine Succinate 6.25 mgAntihistamine

Uses



temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches/pains
  • fever
  • runny nose and sneezing

Liver Warning



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

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Sore Throat Warning



If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
  • 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.
  • to make a child sleep

Otc - Ask Doctor



Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood-thinning drug warfarin.

Otc - When Using



When using this product

  • do not use more than directed
  • excitability may occur especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful with driving a motor vehicle or operating machinery
  • alcohol, sedatives and tranquilizers may increase drowsiness

Otc - Stop Use



Stop use and ask a doctor if

  • pain 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

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 can cause serious health problems. 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.


Directions



  • Take only as recommended—see Overdose warning.
  • do not exceed 4 doses per 24 hours
    adults and children 12 years of age and overswallow 2 softgels with water every 6 hours
    children 4 to under 12 years of ageask a doctor
    children under 4 years of agedo not use
  • When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing


Other Information



  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients



D&C Yellow# 10, FD&C Blue# 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide


Questions Or Comments?



1-888-333-9792


Principal Display Panel



Walgreens

Cold & Flu

COMPARE TO ACTIVE INGREDIENTS IN

VICKS® NYQUIL® LiquiCaps® active ingredients††

MULTI-SYMPTOM

NIGHTTIME COLD & FLU

Acetaminophen 325mg/ ACHES/ FEVER/ SORE THROAT

Dextromethorphan HBr 15mg/ COUGH

Doxylamine Succinate 6.25mg/ SNEEZING/ RUNNY NOSE

Relieves aches, fever, sore throat,

cough, sneezing & runny nose

Actual Size

24 LIQUID CAPS

†††† This product is not manufactured or distributed by

Procter & Gamble, owner of the registered

trademarks Vicks® NyQuil® LiquiCaps®


* Please review the disclaimer below.