Walgreens Nighttime Cold And Flu
FDA Label NDC 0363-1168

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Walgreens Nighttime Cold And Flu (NDC 0363-1168). 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, sore throat warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

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 No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments?

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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

    16 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.