NDC | 37000-033-24, 37000-555-12, 37000-807-12 |
Set ID | 416c6674-e4aa-6375-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | The Procter & Gamble Manufacturing Company |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 30 mL)
- Uses
-
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 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
- 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
- a sodium-restricted diet
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
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 15 mL)
- Uses
-
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if
- adults take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
- child take more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
- 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough 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.
- Directions
- Other information
- Inactive ingredients
- Questions?
-
PRINCIPAL DISPLAY PANEL - Kit Carton
POWERFUL
RELIEF
Day or Night Pack
VICKS ®
DayQuil ™
COLD & FLU
Multi-Symptom Relief
Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr,
-
Headache, Fever, Sore Throat,
Minor Aches & Pains - Nasal Congestion
- Cough
DayQuil 12 FL OZ (354 ml) BOTTLENyQuil ™
COLD & FLU
Nighttime Relief
Acetaminophen,Doxylamine
Succinate, Dextromethorphan HBr
-
Headache, Fever, Sore Throat
Minor Aches & Pains - Sneezing, Runny Nose
- Cough
Alcohol 10%
NyQuil 12 FL OZ (354 ml) BOTTLE
TOTAL 24 FL OZ (708 ml)
-
Headache, Fever, Sore Throat,
-
INGREDIENTS AND APPEARANCE
VICKS DAYQUIL AND VICKS NYQUIL COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-033 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-033-24 1 in 1 PACKAGE; Type 0: Not a Combination Product 08/01/2013 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 354 mL Part 2 1 BOTTLE, PLASTIC 354 mL Part 1 of 2 VICKS DAYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquidProduct Information 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 EDETATE DISODIUM (UNII: 7FLD91C86K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 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) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) 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:37000-555-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/22/2011 Part 2 of 2 VICKS NYQUIL COLD AND FLU NIGHTTIME RELIEF
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate solutionProduct Information Item Code (Source) NDC:37000-807 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL 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 HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) ALCOHOL (UNII: 3K9958V90M) PEG-40 STEARATE (UNII: ECU18C66Q7) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) XANTHAN GUM (UNII: TTV12P4NEE) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color green Score Shape Size Flavor ANISE, MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-807-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/01/2013 Labeler - The Procter & Gamble Manufacturing Company (004238200)