VICKS FLU THERAPY SEVERE COLD AND FLU NIGHT- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powde

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

Buy It Now

Active ingredient:
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Procter & Gamble Manufacturing México, S. de R.L. de C.V.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
temporarily relieves common cold/flu symptoms: - minor aches & pains - sore throat - fever - headache - cough due to minor throat & bronchial irritation - cough to help you sleep - nasal congestion - sinus congestion & pressure - reduces swelling of nasal passages - temporarily restores freer breathing through the nose - promotes nasal and/or sinus drainage - runny nose - sneezing
Authorization status:
OTC monograph final
Authorization number:
58933-926-01

VICKS FLU THERAPY SEVERE COLD AND FLU NIGHT- acetaminophen, diphenhydramine

hydrochloride, and phenylephrine hydrochloride powder, for solution

Procter & Gamble Manufacturing México, S. de R.L. de C.V.

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® Flu Therapy Severe Cold & Flu Night

Drug Facts

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Us es

temporarily relieves common cold/flu symptoms:

minor aches & pains

sore throat

fever

headache

cough due to minor throat & bronchial irritation

cough to help you sleep

nasal congestion

sinus congestion & pressure

reduces swelling of nasal passages

temporarily restores freer breathing through the nose

promotes nasal and/or sinus drainage

runny nose

sneezing

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 6 doses in 24 hours, which is the maximum daily amount for this product

with other drugs containing acetaminophen

3 or more alcoholic drinks every day 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 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

glaucoma

cough that occurs with too much phlegm (mucus)

a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema

trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

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

pain, nasal congestion, or cough gets worse or lasts more than 7 days

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.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical

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

Directions

take only as directed

do not exceed 6 doses per 24 hrs

adults & children 12 yrs & over one packet every 4 hrs

children under 12 yrs do not use

Dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume

entire drink within 10-15 minutes

If using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after

heating. Do not overheat

Other information

potassium 10 mg

phenylketonurics: contains phenylalanine 68 mg per dose

do not exceed 25°C.

Inactive ingredients

acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C

Blue No. 1, FD&C Red No. 40, flavors, sucrose, tribasic calcium phosphate

Ques tions ?

1-800-362-1683

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 6 packet backer card and insert

VICKS ®

NIGHT

FLUTherapy

Acetaminophen - Pain Reliever/Fever reducer, Diphenhydramine HCl-

SEVERE COLD & FLU

Antihistamine/Cough suppressant Phenylephrine HCl - Nasal decongestant

Soothing Vapors +

Relieves:

Nasal Congestion

Sore Throat

Body Aches

Fever

Runny Nose

Cough

HoneyLemon Flavor

6 PACKETS

VICKS FLU THERAPY SEVERE COLD AND FLU NIGHT

acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 9 33-9 26

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

in 5 g

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

in 5 g

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

ACETAMINOPHEN

6 50 mg

in 5 g

Procter & Gamble Manufacturing México, S. de R.L. de C.V.

Inactive Ingredients

Ingredient Name

Stre ng th

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

ASPARTAME (UNII: Z0 H242BBR1)

SUCRO SE (UNII: C151H8 M554)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

TRIBASIC CALCIUM PHO SPHATE (UNII: 9 1D9 GV0 Z28 )

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

CARBO XYMETHYLCELLULO SE (UNII: 0 5JZI7B19 X)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

HONEY (Lemo n)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 9 33-9 26 -0 1

6 in 1 BLISTER PACK

0 4/17/20 19

1

5 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

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 4/17/20 19

Labeler -

Procter & Gamble Manufacturing México, S. de R.L. de C.V. (812807550)

Revised: 4/2019

Similar products

Search alerts related to this product

View documents history

Share this information