VICKS FORMULA 44 COUGH AND HEAD CONGESTION- dextromethorphan hydrobromide liquid

Vicks by

Drug Labeling and Warnings

Vicks 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 (in each 15 mL)

Dextromethorphan HBr 15 mg

Phenylephrine HCl 5 mg

Purpose

Cough suppressant

Nasal decongestant

Use

temporarily relieves common cold symptoms:

• nasal congestion
• cough due to minor throat & bronchial irritation

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, or emphysema
• a sodium-restricted diet

When using this product, do not use more than directed.

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• nasal congestion or cough persist for more than one week or are accompanied by fever
• cough 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

• take only as directed
• use the dose cup provided
• do not exceed 4 doses per 24 hours

adults and children 12 years and over 30 mL every 4 hours

children 6 to under 12 years 15 mL every 4 hours

children 4 to under 6 years ask a doctor

children under 4 years do not use

Other information

• each tablespoon contains: sodium 45 mg
• store at room temperature

Inactive ingredients

citric acid, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER&GAMBLE,

CINCINNATI OH 45202.

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

VICKS®

FORMULA

44™

ATTACKS COUGH AT THE SOURCE

FAST

RELIEF

COUGH &

HEAD CONGESTION

Phenylephrine HCl :
nasal decongestant

Dextromethorphan HBr :

cough suppressant

Non-Drowsy

BERRY FLAVOR

NEW

12 FL OZ (354 ml)

INGREDIENTS AND APPEARANCE

VICKS  FORMULA 44 COUGH AND HEAD CONGESTION
dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-449
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

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-449-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/11/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/11/2017

Labeler - The Procter & Gamble Manufacturing Company (004238200)