VICKS DAYQUIL AND VICKS NYQUIL SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kit

Vicks DayQuil and Vicks NyQuil by

Drug Labeling and Warnings

Vicks DayQuil and 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

DayQuil Severe Cold & Flu

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 15 mL tablespoon)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 4 doses (30 mL each) in 24 hrs
• child takes more than 4 doses (15 mL each) in 24 hrs
• taken 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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
• pain, nasal congestion, or cough gets worse or lasts 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 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 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 ensure correct dosing

Other information

• each 15 mL tablespoon contains: sodium 47 mg
• store at room temperature

Inactive ingredients

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

Questions?

1-800-251-3374

SPL UNCLASSIFIED SECTION

NyQuil Severe Cold & Flu

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 30 mL dose cup)	Purpose
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine
Phenylephrine HCl 10 mg	Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion
• sinus congestion & pressure
• cough due to minor throat & bronchial irritation
• cough to help you sleep
• minor aches & pains
• headache
• fever
• sore throat
• runny nose & sneezing
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage

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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• 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

• you get nervous, dizzy or sleepless
• pain, nasal congestion, 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 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 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 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 ensure correct dosing

Other information

• each 30 mL dose cup contains: sodium 92 mg
• store at room temperature

Inactive ingredients

citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

Dist. by Proctor & Gamble, Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - Kit Carton

NEW
Fights More
Symptoms
than DayQuil/NyQuil
Cold & Flu

VICKS ®

DayQuil®
SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr,
Guaifenesin

MAX
STRENGTH

Non-Drowsy
Alcohol Free

• Headache, Fever, Sore Throat
  Minor Aches & Pains
• Nasal/Sinus Congestion & Sinus Pressure
• Cough
• Chest Congestion

DayQuil Severe ONE 12 FL OZ (354 ml) BOTTLE:
TOTAL 24 FL

NyQuil®
SEVERE

COLD & FLU

Nighttime Relief

Acetaminophen, Phenylephrine HCl, Doxylamine Succinate,
Dextromethorphan HBr

MAX
STRENGTH

Berry Flavor

• Headache, Fever, Sore Throat
  Minor Aches & Pains
• Nasal/Sinus Congestion & Sinus Pressure
• Sneezing, Runny Nose
• Cough

NyQuil Severe ONE 12 FL OZ (354 ml) BOTTLE
OZ (708 ml)

INGREDIENTS AND APPEARANCE

VICKS DAYQUIL AND VICKS NYQUIL  SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-814

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-814-24	1 in 1 PACKAGE	07/22/2013

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   SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution

Product Information
Item Code (Source)	NDC: 37000-810
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-810-12	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	07/22/2013

Part 2 of 2

VICKS NYQUIL   SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution

Product Information
Item Code (Source)	NDC: 37000-812
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	20 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-812-12	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	07/22/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/22/2013

Labeler - The Procter & Gamble Manufacturing Company (004238200)