VICKS ® DayQuil ® COLD & FLU Multi-Symptom Relief - DailyMed

VICKS DAYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled  The Procter & Gamble Manufacturing Company

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.

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VICKS ® DayQuil ® COLD & FLU Multi-Symptom Relief

Drug Facts

Active ingredients (in each LiquiCap)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion
• 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 4 doses in 24 hrs, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Sore throat warning

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
• thyroid disease
• diabetes
• high blood pressure
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 7 days (adults)
• 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

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

• take only as directed - see Overdose warning
• do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	2 LiquiCaps with water every 4 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

• when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing

Other information

• store at room temperature

Inactive ingredients

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

Questions?

1-800-251-3374

Made in Canada Dist. by Procter & Gamble, Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 48 LiquiCap Carton

VICKS ®

DayQuil ®

COLD & FLU

Multi-Symptom Relief

Acetaminophen, Phenylephrine , Dextromethorphan

• Aches, Fever & Sore Throat
• Nasal Congestion
• Cough

Non-Drowsy

48 LiquiCaps™

VICKS DAYQUIL  COLD AND FLU MULTI-SYMPTOM RELIEF acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-558 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8)   FD&C RED NO. 40 (UNII: WZB9127XOA)   GELATIN (UNII: 2G86QN327L)   GLYCERIN (UNII: PDC6A3C0OX)   POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)   POVIDONE (UNII: FZ989GH94E)   PROPYLENE GLYCOL (UNII: 6DC9Q167V3)   WATER (UNII: 059QF0KO0R)   SORBITOL (UNII: 506T60A25R)   TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics Color orange Score no score Shape OVAL Size 21mm Flavor Imprint Code DQuil Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-558-02 2 in 1 POUCH; Type 0: Not a Combination Product 06/09/2011 01/01/2021 2 NDC:37000-558-16 8 in 1 CARTON 06/09/2011 01/01/2021 2 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:37000-558-24 12 in 1 CARTON 06/09/2011 01/01/2021 3 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:37000-558-48 24 in 1 CARTON 06/09/2011 01/01/2021 4 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:37000-558-72 36 in 1 CARTON 06/09/2011 07/07/2017 5 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:37000-558-08 4 in 1 CARTON 06/09/2011 01/01/2021 6 2 in 1 BLISTER PACK; 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 06/09/2011 01/01/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 5/2023 Document Id: fbc01f5d-ad80-5da3-e053-6294a90a3786 34390-5 Set id: 71443525-a9df-4952-a875-23b45a665b45 Version: 17 Effective Time: 20230515  The Procter & Gamble Manufacturing Company