Label: VICKS NYQUIL COUGH- Dextromethorphan Hydrobromide ...

VICKS NYQUIL COUGH- dextromethorphan hydrobromide and doxylamine succinate liquid  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 ® COUGH

Drug Facts

Active ingredients (in each 30 mL dose cup)	Purpose
Dextromethorphan HBr 30 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine

Uses

temporarily relieves cold symptoms:

• cough
• runny nose and sneezing

Warnings

Do not use

• 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

• glaucoma
• excessive 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
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

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, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or occurs with fever, 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.

Directions

• use dose cup or tablespoon (TBSP)
• do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL (2 TBSP) every 6 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

• each 30 mL dose cup contains: sodium 36 mg
• store at room temperature

Inactive ingredients

alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions?

1-800-362-1683

Dist. by Procter & Gamble, Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

50% MORE than our 8 oz size

VICKS®

NyQuil®

COUGH

Doxylamine, Dextromethorphan

• Sneezing, Runny Nose
• Cough

Nighttime Cough Relief

Alcohol 10%

12 FL OZ (354 ml)

VICKS NYQUIL  COUGH dextromethorphan hydrobromide and doxylamine succinate liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-550 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg  in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg  in 30 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M)   CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)   FD&C BLUE NO. 1 (UNII: H3R47K3TBD)   FD&C RED NO. 40 (UNII: WZB9127XOA)   HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)   POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)   PROPYLENE GLYCOL (UNII: 6DC9Q167V3)   WATER (UNII: 059QF0KO0R)   SACCHARIN SODIUM (UNII: SB8ZUX40TY)   SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics Color red Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-550-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/22/2011 07/28/2022 2 NDC:37000-550-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/22/2011 07/28/2022

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/22/2011 07/28/2022

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 7/2022 Document Id: eac35822-916b-e598-e053-2a95a90ac8f1 34390-5 Set id: 3ce20c44-cd07-454a-ad35-797e107aa8d3 Version: 6 Effective Time: 20220728  The Procter & Gamble Manufacturing Company