VICKS NYQUIL COLD AND FLU NIGHTTIME RELIEF- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate solution

Vicks NyQuil by

Drug Labeling and Warnings

Vicks NyQuil by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 30 mL dose cup)	Purpose
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 30 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

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, 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

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
• a sodium-restricted diet

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, and tranquilizers may increase drowsiness

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.

If pregnant or breast-feeding, ask a health professional before use.

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 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 6 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

• each 30 mL dose cup contains: sodium 43 mg
• store at room temperature

Inactive ingredients

alcohol, citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Yellow No. 6, flavor, high fructose corn syrup, PEG-40 stearate, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, xanthan gum

Questions?

1-800-362-1683

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Dist. by
Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

VICKS®

NyQuil®

COLD & FLU

Nighttime Relief

Acetaminophen, Doxylamine, Dextromethorphan

• Aches, Fever & Sore Throat
• Sneezing, Runny Nose
• Cough

Alcohol 10%

8 FL OZ (236 ml)

INGREDIENTS AND APPEARANCE

VICKS NYQUIL  COLD AND FLU NIGHTTIME RELIEF
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-807
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PEG-40 STEARATE (UNII: ECU18C66Q7)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	ANISE, MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-807-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2010
2	NDC: 37000-807-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2010
3	NDC: 37000-807-24	2 in 1 PACKAGE, COMBINATION	06/01/2010
3	NDC: 37000-807-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 37000-807-36	3 in 1 PACKAGE, COMBINATION	06/01/2010
4	NDC: 37000-807-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2010

Labeler - The Procter & Gamble Manufacturing Company (004238200)