VICKS DAYQUIL KIDS HONEY AND VICKS NYQUIL KIDS HONEY COLD AND COUGH PLUS- doxylamine succinate, phenylephrine hydrochloride, dextromethorphan hydrobromide kit

Vicks DayQuil Kids Honey and Vicks NyQuil Kids Honey by

Drug Labeling and Warnings

Vicks DayQuil Kids Honey and Vicks NyQuil Kids Honey 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 Kids HONEY COLD & COUGH + CONGESTION

Drug Facts

Active ingredients (in each 15 mL)

Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

Purpose

Cough suppressant
Antihistamine
Nasal decongestant

Uses

temporarily relieves common cold symptoms:
nasal congestion sinus congestion & pressure
cough due to minor throat & bronchial irritation
cough to help you sleep runny nose & sneezing
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage

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 sleepy

Ask a doctor before use if you have

heart disease

high blood pressure
thyroid disease

diabetes

glaucoma
trouble urinating due to enlarged prostate gland
cough that occurs with too much phlegm (mucus)
a breathing problem or chronic cough that lasts or occurs with smoking, asthma or emphysema

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
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

you get nervous, dizzy or sleepless
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache
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

Keep out of reach of children.

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 4 hrs
• children 6 to under 12 yrs: 15 mL every 4 hrs
• children 4 to under 6 yrs: do not use unless directed by a doctor
• children under 4 yrs: do not use

Other information

• each 15 mL contains: sodium 14 mg
• store at no greater than 25°C

Inactive ingredients

citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor (with honey), glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

DayQuil Kids HONEY COLD & COUGH + MUCUS

Drug Facts

Active ingredients (in each 15 mL)

Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg

Purpose

Cough suppressant
Expectorant
Nasal decongestant

Uses

•  temporarily relieves common cold symptoms:
•  nasal congestion
•  sinus congestion & pressure
•  cough due to minor throat & bronchial irritation
•  cough to help you sleep
•  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

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

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

When using this product,

do not use more than directed.

Stop use and ask a doctor if

you get nervous, dizzy or sleepless
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache
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

Keep out of reach of children.

OVERDOSAGE

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 4 hrs
• children 6 to under 12 yrs: 15 mL every 4 hrs
• children 4 to under 6 yrs: ask a doctor
• children under 4 yrs: do not use

Other information

• each 15 mL contains: sodium 14 mg
• store at no greater than 25°C

Inactive ingredients

citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor (with honey), glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if printed shrinkband seal around the neck is broken or missing.

PRINCIPAL DISPLAY PANEL - Convenience Pack

VALUE COMBO PACK

1 DAY + 1 NIGHT

VICKS ®

DayQuil ™ Kids HONEY

COLD & COUGH + MUCUS

Guaifenesin, Phenylephrine HCl, Dextromethorphan HBr

Chest Congestion
Nasal Congestion
Cough

Non-Drowsy

FREE OF ALCOHOL
& ACETAMINOPHEN

NyQuil ™ Kids HONEY

COLD & COUGH + CONGESTION

Doxylamine Succinate, Phenylephrine HCl, Dextromethorphan HBr

Sneezing, Runny Nose
Nasal Congestion
Cough

​ Nighttime Relief

2 BOTTLES - 1 DAYQUIL/1 NYQUIL 8 FL OZ (236 mL) EACH; TOTAL 16 FL OZ (473 mL)

INGREDIENTS AND APPEARANCE

VICKS DAYQUIL KIDS HONEY AND VICKS NYQUIL KIDS HONEY  COLD AND COUGH PLUS
doxylamine succinate, phenylephrine hydrochloride, dextromethorphan hydrobromide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-993

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-993-16	1 in 1 PACKAGE; Type 0: Not a Combination Product	07/12/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	236 mL
Part 2	1 BOTTLE, PLASTIC	236 mL

Part 1 of 2

VICKS DAYQUIL KIDS  COLD COUGH PLUS MUCUS
guaifenesin, phenylephrine hydrochloride and dextromethorphan hydrobromide liquid

Product Information
Item Code (Source)	NDC: 69423-946
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor	HONEY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-946-08	236 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 Drug	M012	07/08/2021

Part 2 of 2

VICKS NYQUIL KIDS  HONEY COLD COUGH CONGESTION
doxylamine succinate, phenylephrine hydrochloride and dextromethorphan hydrobromide liquid

Product Information
Item Code (Source)	NDC: 69423-983
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor	HONEY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-983-08	236 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 Drug	M012	07/07/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/12/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)