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NDC 37000-0447-12 Vicks 15 mg/15mL Details

Vicks 15 mg/15mL

Vicks is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by The Procter & Gamble Manufacturing Company. The primary component is DEXTROMETHORPHAN HYDROBROMIDE.

Product Information

NDC	37000-0447
Product ID	37000-447_eac438f0-e0c8-81c1-e053-2a95a90afbfb
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Vicks
Proprietary Name Suffix	Formula 44 Cough
Non-Proprietary Name	Dextromethorphan Hydrobromide
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	15
Active Ingredient Units	mg/15mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE
Labeler Name	The Procter & Gamble Manufacturing Company
Pharmaceutical Class	Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 37000-0447-12 (37000044712)

Pricing Information	N/A
NDC Package Code	37000-447-12
Billing NDC	37000044712
Package	354 mL in 1 BOTTLE, PLASTIC (37000-447-12)
Marketing Start Date	2017-07-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4e76fd19-8f11-683a-e054-00144ff8d46c Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 15 mL)

Dextromethorphan HBr 15 mg

Purpose

Cough suppressant

Use

temporarily relieves cough due to minor throat and bronchial irritation associated with a cold

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

cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 6-8 hours

children 6 to under 12 years 15 mL every 6-8 hours

children 4 to under 6 years ask a doctor

children under 4 years do not use

Other information

each 15 mL contains: 12 mg
store at room temperature no greater than 25º C
does not meet USP requirements for light resistant packaging

Inactive ingredients

citric acid, FD&C Red No. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

DIST. BYPROCTER&GAMBLE,

CINCINNATI OH 45202.

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

VICKS®

FORMULA

44™DM

COUGH

Dextromethorphan HBr:

cough suppressant

ATTACKS COUGH AT THE SOURCE

Non-Drowsy

BERRY FLAVOR

NEW

12 FL OZ (354 ml)

INGREDIENTS AND APPEARANCE

VICKS FORMULA 44 COUGH

dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-447
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-447-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/11/2017

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

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 10/2022

Document Id: eac438f0-e0c8-81c1-e053-2a95a90afbfb

Set id: 4e76fd19-8f11-683a-e054-00144ff8d46c

Version: 4

Effective Time: 20221011

Search by Drug Name or NDC

NDC 37000-0447-12 Vicks 15 mg/15mL Details

Vicks 15 mg/15mL

Product Information

Package

Package Images

NDC 37000-0447-12 (37000044712)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4e76fd19-8f11-683a-e054-00144ff8d46c Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 15 mL)

Purpose

Use

Warnings

Ask a doctor before use if you have

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

INGREDIENTS AND APPEARANCE

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