VICKS CHILDRENS COUGH CONGESTION NIGHT- phenylephrine hydrochlorice and diphenhydramine hydrochloride liquid

Vicks childrens by

Drug Labeling and Warnings

Vicks childrens 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 ingredients (in each 15 mL)

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

Antihistamine/Cough suppressant
Nasal decongestant

Uses

temporarily relieves common cold symptoms:

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

Warnings

Do not use

• with any other product containing diphenhydramine, even one used on skin
• to make a child sleepy
• 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
• 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
• 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
• 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

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 44 mg
• store at no greater than 25ºC.

Inactive ingredients

anhydrous citric acid, flavor, glycerin, polysorbate 20, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

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

Made in Canada

PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label

VICKS®

children's

Cough

Congestion Night

Phenylephrine HCI - nasal decongestant
Diphenhydramine HCI -
antihistamine/cough suppressant

FREE of:

Artificial Dyes & Flavors,

High Fructose Corn Syrup & Alcohol

• Cough
• Runny nose
• Stuffy nose
• Sneezing

Ages 6+

6 FL OZ (177 ml)

INGREDIENTS AND APPEARANCE

VICKS CHILDRENS  COUGH CONGESTION NIGHT
phenylephrine hydrochlorice and diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-712
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-712-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/22/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)