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

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]

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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.

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 (with honey), glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

Questions?

1-800-362-1683

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

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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

INGREDIENTS AND APPEARANCE

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: 69423-983
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: 69423-983-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/07/2021

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

Labeler - The Procter & Gamble Manufacturing Company (004238200)