VICKS DAYQUIL TROPICAL AND VICKS NYQUIL CHERRY COUGH- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kit

Vicks DayQuil Tropical and Vicks NyQuil Cherry by

Drug Labeling and Warnings

Vicks DayQuil Tropical and Vicks NyQuil Cherry 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

NyQuil Cough

Drug Facts

Active ingredients (in each 30 mL)

Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg

Purpose

Cough suppressant
Antihistamine

Uses

temporarily relieves common cold symptoms:

• cough due to minor throat and bronchial irritation
• 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.

Ask a doctor before use if you have

• 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.

When using this product

• 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take only as directed
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over 30 mL every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Other information

• each 30 mL tablespoon 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

SPL UNCLASSIFIED SECTION

DayQuil Cough

Drug Facts

Active ingredients (in each 15 mL)

Dextromethorphan HBr 15 mg

Purpose

Cough suppressant

Uses

temporarily relieves cough due to minor throat & bronchial irritation associated with a cold

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.

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor if

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take only as directed
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over 30 mL every 6-8 hrs
children 6 to under 12 years 15 mL every 6-8 hours

children 4 to under 6 years ask a doctor
children under 4 yrs do not use

Other information

• each 15 mL contains: sodium 15 mg
• store at room temperature
• does not meet USP requirements for light resistant packaging

Inactive ingredients

citric acid, D&C Yellow No. 10, FD&C Yellow No. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions?

1-800-362-1683

PRINCIPAL DISPLAY PANEL - Kit Carton

FAST COUGH

RELIEF

Day or Night

VICKS ®

DayQuil ™

COUGH

COUGH SUPPRESSANT

Dextromethorphan HBr- Cough Suppressant

8 HR

Powerful Cough Relief

for up to 8 hours

• Non-Drowsy

Soothing Tropical Blend

Alcohol Free

Antihistamine Free

DayQuil 12 FL OZ (354 ml) BOTTLE

NyQuil ™

COUGH

COUGH SUPPRESSANT

Doxylamine Succinate - Antihistamine

Dextromethorphan HBr - Cough Suppressant

• Powerful Cough Relief so you can sleep
• Nighttime Relief

Soothing Cherry

Alcohol 10%

NyQuil 12 FL OZ (354 ml) BOTTLE

TOTAL 24 FL OZ (708 ml)

INGREDIENTS AND APPEARANCE

VICKS DAYQUIL TROPICAL AND VICKS NYQUIL CHERRY  COUGH
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-034

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-034-24	1 in 1 PACKAGE; Type 0: Not a Combination Product	08/01/2013

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	354 mL
Part 2	1 BOTTLE, PLASTIC	354 mL

Part 1 of 2

VICKS DAYQUIL  COUGH
dextromethorphan hydrobromide liquid

Product Information
Item Code (Source)	NDC: 37000-565
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-565-12	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	06/22/2011

Part 2 of 2

VICKS NYQUIL  COUGH
dextromethorphan hydrobromide and doxylamine succinate liquid

Product Information
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
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
ALCOHOL (UNII: 3K9958V90M)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
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: 37000-550-12	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	06/22/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2013

Labeler - The Procter & Gamble Manufacturing Company (004238200)