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Name:Vicks Dayquil Cold And Flu
Manufacturer:The Procter & Gamble Manufacturing Company
Category:Over-the-counter (OTC) Marketed Drugs


VICKS® DayQuil® COLD & FLU

VICKS DAYQUIL  COLD AND FLU - acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
The Procter & Gamble Manufacturing Company

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.

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VICKS®
DayQuil®
COLD & FLU

Drug Facts

Active ingredients (in each 15 mL tablespoon) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if adult/child takes

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • adult has 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, 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.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet

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
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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 & for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed - see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 30 mL (2 TBSP) every 4 hrs
children 6 to under 12 yrs 15 mL (1 TBSP) every 4 hrs
children 4 to under 6 yrs ask a doctor
children under 4 yrs do not use
  • when using other DayQuil or NyQuil® products, carefully read each label to insure correct dosing

Other information

  • each tablespoon contains: sodium 50 mg
  • store at room temperature

Inactive ingredients

carboxymethylcellulose sodium, citric acid, disodium EDTA, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Questions?

1-800-251-3374
www.vicks.com

Dist. by Procter & Gamble,
Cincinnati, OH 45202.

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

50% MORE
than our 8 oz size

VICKS®

DayQuil®

COLD & FLU

Multi-Symptom Relief

Acetaminophen, Phenylephrine, Dextromethorphan

  • Aches, Fever & Sore Throat
  • Nasal Congestion
  • Cough

Non-Drowsy
Alcohol Free / Antihistamine Free

12 FL OZ
(354 ml)

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

VICKS DAYQUIL   COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-555
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 325 mg  in 15 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 10 mg  in 15 mL
Phenylephrine Hydrochloride (phenylephrine) Phenylephrine Hydrochloride 5 mg  in 15 mL
Inactive Ingredients
Ingredient Name Strength
carboxymethylcellulose sodium  
citric acid monohydrate  
Edetate Disodium  
FD&C Yellow No. 6  
glycerin  
propylene glycol  
water  
saccharin sodium  
sodium benzoate  
sodium chloride  
sodium citrate  
sorbitol  
sucralose  
Product Characteristics
Color ORANGE Score     
Shape Size
Flavor APRICOT Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-555-08 240 mL in 1 BOTTLE, PLASTIC None
2 NDC:37000-555-12 360 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 06/22/2011

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 06/2011 The Procter & Gamble Manufacturing Company



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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