Label: VICKS DAYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
- NDC Code(s): 37000-555-04, 37000-555-06, 37000-555-08, 37000-555-12
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated May 30, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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
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.
Acetaminophen may cause severe skin reactions.
Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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
- 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
- a sodium-restricted diet
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.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label
INGREDIENTS AND APPEARANCE
VICKS DAYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-555 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color orange Score Shape Size Flavor APRICOT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-555-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/22/2011 01/01/2024 2 NDC:37000-555-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/22/2011 01/01/2024 3 NDC:37000-555-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/12/2022 01/01/2024 4 NDC:37000-555-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/13/2021 01/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M012 06/22/2011 01/01/2024 Labeler - The Procter & Gamble Manufacturing Company (004238200)