Label: VICKS NYQUIL ELDERBERRY COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
- NDC Code(s): 84126-308-12
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 7, 2024
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- Active ingredients (in each 15 mL)
- Purpose
- Uses
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Warnings
Liver warning:
This product contains acetaminophen.
Severe liver damage may occur if- adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
- child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product
- taken with other drugs containing acetaminophen
- adult has 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
- 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
- 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
- pain or cough gets worse or lasts 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.
- Directions
- Other information
- Inactive ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label
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INGREDIENTS AND APPEARANCE
VICKS NYQUIL ELDERBERRY COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84126-308 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg in 15 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color purple Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84126-308-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/09/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/09/2024 Labeler - The Procter & Gamble Manufacturing Company (004238200)