Label: DAYTIME NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
- NDC Code(s): 0363-0566-40, 0363-0666-40, 0363-1733-02
- Packager: Walgreen 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.
Drug Label Information
Updated June 1, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Nighttime Cold & FluActive ingredients (in each 30 mL)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough as occurs with smoking, asthma, or emphysema
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- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
When using this product
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- excitability may occur, especially in children
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- marked drowsiness may occur
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- avoid alcoholic drinks
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- be careful when driving a motor vehicle or operating machinery
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- alcohol, sedatives, and tranquilizers may increase drowsiness
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Daytime Cold & FluActive ingredients (in each 15 mL)
- Purpose
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- •
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- •
- child takes more than 5 doses in 24 hours
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- taken with other drugs containing acetaminophen
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- 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.
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
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- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
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- you get nervous, dizzy or sleepless
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- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- 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 or comments?
-
Package/Label Principal Display Panel
DAY & NIGHT PACK
Walgreens
WALGREENS PHARMACIST RECOMMENDED
Compare to the active ingredients in Vicks® DayQuil® & Vicks® NyQuil®
DAYTIME
NON-DROWSY
Cold & Flu
ACETAMINOPHEN / ACHES / FEVER / SORE THROAT
DEXTROMETHROPHAN HBr / COUGH
PHENYLEPHRINE HCl / NASAL CONGESTION
Multi-Symptom
• Pain reliever, fever reducer, cough suppressant & nasal decongestant
• Antihistamine free
• Alcohol free
NIGHTTIME
Cold & Flu
ACETAMINOPHEN / ACHES / FEVER / SORE THROAT
DEXTROMETHORPHAN HBr / COUGH
DOXYLAMINE SUCCINATE / SNEEZING / RUNNY NOSE
Multi-Symptom
• Pain reliever, fever reducer, cough suppressant & antihistamine
• ALCOHOL 10%
Cherry flavor
2 – 12 FL OZ (355 mL) BOTTLES / TOTAL 24 FL OZ (1.5 pt) (710 mL)
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INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1733 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1733-02 1 in 1 CARTON; Type 0: Not a Combination Product 07/13/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 355 mL Part 2 1 BOTTLE 355 mL Part 1 of 2 COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate solutionProduct Information Item Code (Source) NDC:0363-0566 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 ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Product Characteristics Color RED (Clear/Dark Red) Score Shape Size Flavor CHERRY (Menthol Aroma) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0566-40 355 mL in 1 BOTTLE; 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 08/16/2011 Part 2 of 2 COLD AND FLU
acetaminophen, dextromethorphan hbr, phenylephrine hcl solutionProduct Information Item Code (Source) NDC:0363-0666 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 BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color ORANGE (clear) Score Shape Size Flavor MENTHOL (with fruit) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0666-40 355 mL in 1 BOTTLE; 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 02/07/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/13/2017 Labeler - Walgreen Company (008965063)