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.

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Vicks ®NIGHT Flu Therapy SEVERE COLD & FLU

Drug Facts

Active ingredients (in each Packet)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purpose

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.

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
AgeDose
adults & children 12 yrs & overone packet every 4 hours
children under 12 yrsdo 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

  • each packet contains: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

Tamper Evident:Do not use if inner sealed packet is torn or broken.

MADE IN MEXICO

DIST. BY:

PROCTER & GAMBLE

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 9 PACKETS Carton

50% MORE

VICKS ®

NIGHT

FluTherapy

SEVERE COLD & FLU

Acetaminophen- Pain reliever/Fever reducer,

Diphenhydramine HCl - Antihistamine/Cough suppressant

Phenylephrine HCl - Nasal decongestant

  • Fast Relief of Cold & Flu symptoms
  • Soothing Vicks Vapors

HONEY LEMON FLAVOR


9 PACKETS

926

VICKS FLU THERAPY  SEVERE COLD AND FLU NIGHT
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58933-926
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 g
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 5 g
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 5 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorHONEY (Lemon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58933-926-016 in 1 BLISTER PACK04/17/201907/21/2022
15 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:58933-926-029 in 1 BLISTER PACK08/04/202001/28/2024
29 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/17/201901/28/2024
Labeler - Procter & Gamble Manufacturing México, S. de R.L. de C.V. (812807550)

Revised: 10/2023
 
Procter & Gamble Manufacturing México, S. de R.L. de C.V.