VICKS NYQUIL HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD AND FLU PLUS CONGESTION- acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution

Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM by

Drug Labeling and Warnings

Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM by is a Otc medication manufactured, distributed, or labeled by Procter & Gamble Manufactura S de RL de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each Packet)

Acetaminophen650 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.

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

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.
• with any other product containing diphenhydramine, even one used on the skin.
• 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 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

Keep out of reach of children.

OVERDOSAGE

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

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

• Age: Dose
• Adults & children 12 yrs & over: one packet (dose) every 4 hours
• Children under 12 yrs: Do not use

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

SPL UNCLASSIFIED SECTION

Tamper Evident: Do not use if sachet is opened or torn

Keep outer package for complete product information.

SPL UNCLASSIFIED SECTION

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 8 packet package

MAX STRENGTH

Vicks® NyQuil™ HOT REMEDY

RAPID RELIEF MULTI-SYMPTOM

COLD & FLU + CONGESTION

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose, Cough

Nasal Congestion, Sinus Pressure

Nighttime Relief

HONEY LEMON FLAVORED

8 POWDER PACKETS

INGREDIENTS AND APPEARANCE

VICKS NYQUIL HOT REMEDY RAPID RELIEF MULTI-SYMPTOM  COLD AND FLU PLUS CONGESTION
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58933-551
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
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 5 g
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 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: 58933-551-01	5 g in 1 PACKET; Type 0: Not a Combination Product	03/22/2023
2	NDC: 58933-551-08	8 in 1 PACKAGE	03/22/2023
2		5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/22/2023

Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)

Establishment
Name	Address	ID/FEI	Business Operations
DIVI'S LABORATORIES LIMITED		676446492	api manufacture(58933-551)

Establishment
Name	Address	ID/FEI	Business Operations
Kongo Chemical Co., Ltd.		690908686	api manufacture(58933-551)