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Vicks DayQuil Severe Cold and Flu

Medically reviewed on Jun 1, 2018

Dosage form: tablet
Ingredients: Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Guaifenesin 200mg, Phenylephrine Hydrochloride 5mg
Labeler: JC World Bell Wholesale Co., Inc.
NDC Code: 50269-811

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.

Vicks® DayQuil®
Severe Cold & Flu

Drug Facts

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses
  • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • sinus congestion & pressure
    • cough due to minor throat & bronchial irritation
    • minor aches & pains
    • headache
    • fever
    • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Liver warning

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

  • more than 4 doses in 24 hrs, 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, 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.
  • 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.

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • 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 directed 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 directed - see Overdose warning
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over2 caplets with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
  • when using other DayQuil or NyQuil® products, carefully read each label to ensure correct dosing

Other information
  • each caplet contains: sodium 4 mg
  • store at room temperature

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C Yellow No. 6, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions?

1-800-251-3374

Product repackaged and distributed with permission of the manufacturer by:

JC World Bell Wholesale Company, Inc. Hacensack, NJ 07601

Package Label

NEW Fights More Symptoms than DayQuil Cold & Flu

VICKS®

DayQuil® SEVERE COLD & FLU Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin

MAX STRENGTH Non-Drowsy

•Headache, Fever, Sore Throat, Minor Aches & Pains •Nasal/Sinus Congestion & Sinus Pressure •Cough •Chest Congestion

25 PACKETS OF 2 COATED CAPLETS

VICKS DAYQUIL   SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50269-811
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg
Guaifenesin (Guaifenesin) Guaifenesin200 mg
Phenylephrine Hydrochloride (phenylephrine) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium 
crospovidone 
FD&C Yellow No. 6 
maltodextrin 
cellulose, microcrystalline 
polyethylene glycols 
polysorbate 80 
polyvinyl alcohol 
povidones 
silicon dioxide 
stearic acid 
talc 
titanium dioxide 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize19mm
FlavorImprint CodeDQ
Contains    
Packaging
#Item CodePackage Description
1NDC:50269-811-2525 PACKET in 1 BOX
12 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/01/2015
Labeler - JC World Bell Wholesale Co., Inc. (805257581)
Establishment
NameAddressID/FEIOperations
Procter & Gamble Manufactura, S. de R.L. de C.V. 812807550manufacture(50269-811)

 
JC World Bell Wholesale Co., Inc.

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Further information

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

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