VICKS DAYQUIL HOT REMEDY COLD AND FLU- acetaminophen, dextromethorphan hbr powder, for solution

Vicks DayQuil HOT REMEDY by

Drug Labeling and Warnings

Vicks DayQuil HOT REMEDY 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

Vicks® DayQuil™ HOT REMEDY COLD & FLU

Drug Facts

Active Ingredients (in each Packet)

Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Purpose

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough

Uses

temporarily relieves common cold/flu symptoms:

• 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 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
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain 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
• 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 64 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, flavor, sodium citrate, sucrose, tricalcium 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

NEW FORMULA

Vicks ®DayQuil™ HOT REMEDY

COLD & FLU

Acetaminophen,

Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough

HONEY LEMON FLAVORED

Non-Drowsy

8 POWDER PACKETS

INGREDIENTS AND APPEARANCE

VICKS DAYQUIL HOT REMEDY  COLD AND FLU
acetaminophen, dextromethorphan hbr powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58933-552
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg  in 5 g
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 g

Inactive Ingredients
Ingredient Name	Strength
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
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)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58933-552-01	5 g in 1 PACKET; Type 0: Not a Combination Product	06/11/2025
2	NDC: 58933-552-08	8 in 1 PACKAGE	06/11/2025
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	06/11/2025

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