VICKS COUGH AND COLD SEVERE- acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)
Available from:
Procter & Gamble Manufacturing Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
temporarily relieves common cold/flu symptoms: - nasal congestion - cough due to minor throat & bronchial irritation - sore throat - headache - minor aches & pains - fever
Authorization status:
OTC monograph final
Authorization number:
37000-768-06

VICKS COUGH AND COLD SEVERE- acetaminophen, chlorpheniramine maleate, and

dextromethorphan hydrobromide liquid

Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

VICKS

Cough & Cold Severe

Drug Facts

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

nasal congestion

cough due to minor throat & bronchial irritation

sore throat

headache

minor aches & pains

fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this

product

child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this

product

taken with other drugs containing acetaminophen

adult has 3 or more alcoholic drinks daily while using this product

Allergy Alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

Skin reddening

Blisters

Rash

®

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever,

headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure

whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

liver disease

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to enlarged prostate gland

cough that occurs with too much phlegm (mucus)

peristent or chronic cough such as occurs with smoking, asthma, or emphysema

a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product, do not use more than directed

Stop use and ask a doctor if

you get nervous, dizzy or sleepless

pain, nasal congestion or cough gets worse or lasts more than 5 days (children) 7 days (adults)

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

cough comes back, or occurs with 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. Quick medical

attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

take only as directed

only use the 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 ask a doctor

children under 4 yrs do not use

Other information

each 15 mL contains: sodium 44 mg

Store at no greater than 25C. Do not refrigerate.

Inactive ingredients

anhydrous citric acid, beta carotene, flavor, glycerin, propylene glycol, purified water, saccharin

sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Ques tions ?

1-800-362-1683

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

Made in Canada

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

VICKS

MAX Strength

Cough & Cold SEVERE

Acetaminophen - pain reliever/fever reducer

Dextromethorphan HBr - cough suppressant

Phenylephrine HCl - nasal decongestant

FREE OF:

Artificial Dyes & Flavors,

Alcohol

High Fructose Corn Syrup

Non-Drowsy

8 FL OZ (236 ml)

VICKS COUGH AND COLD SEVERE

acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:370 0 0 -76 8

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Procter & Gamble Manufacturing Company

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

in 15 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

in 15 mL

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

in 15 mL

Inactive Ingredients

Ingredient Name

Stre ng th

XANTHAN GUM (UNII: TTV12P4NEE)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

BETA CARO TENE (UNII: 0 1YAE0 3M7J)

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics

Color

o ra nge

S core

S hap e

S iz e

Flavor

ORANGE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:370 0 0 -76 8 -

236 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/23/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 4/23/20 19

Labeler -

Procter & Gamble Manufacturing Company (004238200)

Revised: 4/2019

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