VICKS FLU THERAPY SEVERE COLD AND FLU NIGHT- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution

VIcks Flu Therapy by

Drug Labeling and Warnings

VIcks Flu Therapy by is a Otc medication manufactured, distributed, or labeled by Procter & Gamble Manufacturing México, S. de R.L. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses

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

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

VICKS FLU THERAPY  SEVERE COLD AND FLU NIGHT
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58933-926
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 g
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 5 g
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 5 g

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ASPARTAME (UNII: Z0H242BBR1)
SUCROSE (UNII: C151H8M554)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	HONEY (Lemon)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58933-926-01	6 in 1 BLISTER PACK	04/17/2019
1		5 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/17/2019

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