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Name:Vicks Nyquil Sinex
Manufacturer:The Procter & Gamble Manufacturing Company
Category:Over-the-counter (OTC) Marketed Drugs


NyQuil®Sinex®

VICKS NYQUIL SINEX - acetaminophen, doxylamine succinate and phenylephrine hydrochloride capsule, liquid filled 
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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NyQuil®
Sinex®

Drug Facts

Active ingredients (in each LiquiCap) Purpose
Acetaminophen 325 mg Pain reliever
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant

Uses

temporarily relieves nasal & sinus symptoms:

  • sinus pain
  • headache
  • nasal & sinus congestion
  • runny nose & sneezing

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 daily while using this product

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

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

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

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 when driving a motor vehicle or operating machinery
  • alcohol, sedatives & tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • redness or swelling is present
  • you get nervous, dizzy or sleepless
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • symptoms do not get better within 7 days or are accompanied by a fever

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

adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs
children 4 to under 12 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

  • store at room temperature

Inactive ingredients

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

Questions?

1-800-362-1683

www.vicks.com

PRINCIPAL DISPLAY PANEL - 20 LiquiCaps Carton

NEW NAME
SAME RELIEF

VICKS®

NyQuil®
Sinex®

NIGHTTIME SINUS RELIEF

Acetaminophen, Doxylamine, Phenylephrine

  • Sinus Headache and Pain
  • Runny Nose
  • Sinus Pressure and Congestion

20 LiquiCaps®

See new warnings and dosing information.

PRINCIPAL DISPLAY PANEL - 20 LiquiCaps Carton

VICKS NYQUIL SINEX 
acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-806
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 325 mg
Doxylamine succinate (Doxylamine) Doxylamine succinate 6.25 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code VS;NIGHT
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-806-20 1 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 20 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BLISTER PACK This package is contained within the CARTON (37000-806-20)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/06/2010

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 04/2010 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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