Label: VICKS DAYQUIL HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD AND FLU PLUS CONGESTION- acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
- NDC Code(s): 58933-550-01, 58933-550-08
- Packager: Procter & Gamble Manufactura S de RL de CV
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 18, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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Uses
temporarily relieves common cold/flu symptoms:
• minor aches & pains
• sore throat
• fever
• headache
• cough due to minor throat & bronchial irritation
• cough to help you sleep
• nasal congestion
• sinus congestion & pressure
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
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Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- trouble urinating due to enlarged prostate gland
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion, 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.
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Directions
take only as directed
do not exceed 6 doses per 24 hrs
Dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes
If using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat
Age Dose adults & children 12 yrs & over one packet (dose) every 4 hours children under 12 yrs do not use - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 packet package
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INGREDIENTS AND APPEARANCE
VICKS DAYQUIL HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD AND FLU PLUS CONGESTION
acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58933-550 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 5 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 g DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 5 g Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ASPARTAME (UNII: Z0H242BBR1) SUCROSE (UNII: C151H8M554) FD&C RED NO. 40 (UNII: WZB9127XOA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) Product Characteristics Color white Score Shape Size Flavor HONEY (Lemon) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58933-550-01 5 g in 1 PACKET; Type 0: Not a Combination Product 03/22/2023 2 NDC:58933-550-08 8 in 1 PACKAGE 03/22/2023 2 5 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/22/2023 Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)