Vicks NyQuil Kids Honey Cold & Cough + Congestion

Vicks NyQuil Kids by

Drug Labeling and Warnings

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

Drug Details [pdf]

VICKS NYQUIL KIDS HONEY COLD COUGH CONGESTION- doxylamine succinate, phenylephrine hydrochloride and dextromethorphan hydrobromide liquid 
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Vicks 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 as 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.

Overdose warning

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

Directions

take only as directed

only use 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 25ºC

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, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

Questions?

1-800-362-1683

DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

VICKS®

NyQuil™

Kids

HONEY

COLD & COUGH + CONGESTION

Doxylamine Succinate, Phenylephrine HCl, Dextromethorphan HBr

Sneezing, Runny Nose
Nasal Congestion
Cough

AGES 6+

8 FL OZ (236 mL)

Nighttime Relief

FREE OF ALCOHOL

& ACETAMINOPHEN

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-945
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
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: 69423-945-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/07/2021	07/07/2021

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

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2022

Document Id: efa4fc2e-73b9-44de-e053-2995a90a70b8

34390-5

Set id: c6b2d866-ae90-2816-e053-2995a90aeab3

Version: 4

Effective Time: 20221212

 

The Pr