Label: VICKS DAYQUIL AND NYQUIL VAPOCOOL SEVERE COLD AND FLU PLUS CONGESTION- acetaminophen, phenylephrine hydrochloride, and doxylamine succinate kit
- NDC Code(s): 69423-988-24, 69423-988-48
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each caplet)
-
Uses
- temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- minor aches & pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
-
Warnings
Liver warning:
This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 8 caplets 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
-
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
- Ask a doctor or pharmacist before use if you are
- When using this product,
-
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.
- If pregnant or breast-feeding,
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each caplet)
-
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- cough to help you sleep
- minor aches & pains
- headache
- fever
- sore throat
- runny nose & sneezing •reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
-
Warnings
Liver warning:
This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 8 caplets 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
-
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
- Ask a doctor or pharmacist before use if you are
- When using this product
-
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.
- If pregnant or breast-feeding,
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- Directions
- Other information
-
Inactive ingredients
crospovidone, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
- Questions?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - Kit Carton
Vicks®
DayQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION
Acetaminophen, Guaifenesin, Phenylephrine HCl, Dextromethorphan HBr
Headache, Fever, Sore Throat, Minor Aches & Pains
Chest Congestion, Thins & Loosens Mucus
Nasal Congestion, Sinus Pressure
Cough
32 DAYQUIL COATED CAPLETS
NyQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION
Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr
Headache, Fever, Sore Throat, Minor Aches & Pains
Nasal Congestion, Sinus Pressure
Sneezing, Runny Nose
Cough
16 NYQUIL COATED CAPLETS
32 DAYQUIL COATED CAPLETS, 16 NYQUIL COATED CAPLETS: 48 TOTAL COATED CAPLETS
-
INGREDIENTS AND APPEARANCE
VICKS DAYQUIL AND NYQUIL VAPOCOOL SEVERE COLD AND FLU PLUS CONGESTION
acetaminophen, phenylephrine hydrochloride, and doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-988 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-988-24 1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package 03/22/2021 2 NDC:69423-988-48 1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package 03/22/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 16 BLISTER PACK 16 Part 2 8 BLISTER PACK 8 Part 1 of 2 VICKS DAYQUIL VAPOCOOL SEVERE COLD AND FLU PLUS CONGESTION
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tabletProduct Information Item Code (Source) NDC:69423-987 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ALUMINUM OXIDE (UNII: LMI26O6933) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MALTODEXTRIN (UNII: 7CVR7L4A2D) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) CROSPOVIDONE (UNII: 2S7830E561) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) TALC (UNII: 7SEV7J4R1U) SUCRALOSE (UNII: 96K6UQ3ZD4) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color orange Score no score Shape OVAL Size 19mm Flavor Imprint Code DQ Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 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 Drug M012 08/01/2018 Part 2 of 2 VICKS NYQUIL VAPOCOOL SEVERE COLD AND FLU PLUS CONGESTION
acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide tablet, coatedProduct Information Item Code (Source) NDC:69423-986 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ALUMINUM OXIDE (UNII: LMI26O6933) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) STEARIC ACID (UNII: 4ELV7Z65AP) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) SUCRALOSE (UNII: 96K6UQ3ZD4) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color green Score no score Shape OVAL Size 19mm Flavor Imprint Code NQ Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 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 Drug M012 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/22/2021 Labeler - The Procter & Gamble Manufacturing Company (004238200)