VICKS NYQUIL COUGH- dextromethorphan hydrobromide and doxylamine succinate liquid

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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 30 mL dose cup)	Purpose
Dextromethorphan HBr 30 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine

Uses

temporarily relieves cold symptoms:

• cough
• runny nose and sneezing

Warnings

Do not use

• 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

• glaucoma
• excessive 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.

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

• cough lasts more than 7 days, comes back, or occurs with fever, 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• 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 36 mg
• store at room temperature

Inactive ingredients

alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

Dist. by
Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

50% MORE
than our
8 oz size

VICKS®

NyQuil®

COUGH

Doxylamine, Dextromethorphan

• Sneezing, Runny Nose
• Cough

Nighttime Cough Relief

Alcohol 10%

12 FL OZ
(354 ml)

INGREDIENTS AND APPEARANCE

VICKS NYQUIL  COUGH
dextromethorphan hydrobromide and doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-550
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-550-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/22/2011
2	NDC: 37000-550-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/22/2011

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)