VICKS CHILDRENS NYQUIL COLD AND COUGH MULTI-SYMPTOM RELIEF- chlorpheniramine maleate and dextromethorphan hydrobromide solution

Vicks Childrens NyQuil by

Drug Labeling and Warnings

Vicks Childrens 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

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 15 mL tablespoon)	Purpose
Chlorpheniramine maleate 2 mg	Antihistamine
Dextromethorphan HBr 15 mg	Cough suppressant

Uses

temporarily relieves cold symptoms:

• cough due to minor throat & bronchial irritation
• sneezing
• runny nose

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 sleep

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

• 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, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or occurs with fever, 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• use dose cup or tablespoon (TBSP)
• do not exceed 4 doses per 24 hrs

• adults & children 12 yrs & over: 30 mL (2 TBSP) every 6 hrs
• children 6 to under 12 yrs: 15 mL (1 TBSP) every 6 hrs
• children 4 to under 6 yrs: ask a doctor
• children under 4 yrs: do not use

Other information

• each tablespoon contains: sodium 71 mg
• store at room temperature

Inactive ingredients

citric acid, FD&C Red No. 40, flavor, potassium sorbate, propylene glycol, purified water, sodium citrate, sucrose

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

VICKS®

Children's
NyQuil ®

COLD & COUGH
Multi-Symptom Relief

Chlorpheniramine, Dextromethorphan

• Sneezing
• Runny Nose
• Cough

Alcohol, Aspirin &
Acetaminophen Free

Cherry
Flavor

8 FL OZ (236 ml)

INGREDIENTS AND APPEARANCE

VICKS CHILDRENS NYQUIL  COLD AND COUGH MULTI-SYMPTOM RELIEF
chlorpheniramine maleate and dextromethorphan hydrobromide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-556
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

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: 37000-556-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/22/2011	03/18/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/22/2011	03/18/2022

Labeler - The Procter & Gamble Manufacturing Company (004238200)