Label: VICKS NYQUIL COLD AND FLU NIGHTTIME RELIEF ...

VICKS NYQUIL COLD AND FLU NIGHTTIME RELIEF- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate 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 ® NyQuil ® COLD & FLU

Drug Facts

Active ingredients (in each LiquiCap)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 15 mg	Cough suppressant
Doxylamine succinate 6.25 mg	Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
• runny nose & sneezing

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

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.
• to make a child sleep

Ask a doctor before use if you have

• liver disease
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, & tranquilizers may increase drowsiness

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.

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
• do not exceed 8 LiquiCaps per 24 hrs

adults & children 12 yrs & over	2 LiquiCaps with water every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other information

• • store at no greater than 25°C

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

Questions?

1-800-362-1683

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

PRINCIPAL DISPLAY PANEL

VICKS®

NyQuil®

COLD & FLU

Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

• Headache, Fever, Sore Throat, Minor Aches & Pains
• Sneezing, Runny Nose
• Cough

Nighttime Relief

16 LiquiCaps ®

VICKS NYQUIL  COLD AND FLU NIGHTTIME RELIEF acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-557 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)   FD&C BLUE NO. 1 (UNII: H3R47K3TBD)   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 green Score no score Shape OVAL Size 21mm Flavor Imprint Code NQUIL Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-557-02 2 in 1 POUCH; Type 0: Not a Combination Product 06/09/2011 01/01/2021 2 NDC:37000-557-16 8 in 1 CARTON 06/09/2011 01/01/2021 2 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:37000-557-24 12 in 1 CARTON 06/09/2011 01/01/2021 3 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:37000-557-48 24 in 1 CARTON 06/09/2011 01/01/2021 4 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:37000-557-72 36 in 1 CARTON 06/09/2011 10/16/2017 5 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:37000-557-08 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 M012 06/09/2011 01/01/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 2/2023 Document Id: f4481800-7fd4-38b0-e053-2a95a90a8893 34390-5 Set id: 9090d896-7d6f-4080-97de-bd08f62f613b Version: 16 Effective Time: 20230209  The Procter & Gamble Manufacturing Company