Label: WALGREEN DAY TIME NIGHTTIME COLD AND FLU RELIEF HONEY FLAVOR- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride,guaifenesin kit
-
Contains inactivated NDC Code(s)
NDC Code(s): 0363-6120-24 - Packager: WALGREENS CO.
- 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 March 4, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 15 mL) – NightTime
- Purpose
-
Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- sinus congestion and pressure
- •
- minor aches and pains
- •
- headache
- •
- fever
- •
- sore throat
- •
- runny nose and sneezing
- •
- cough due to minor throat and bronchial irritation
- •
- cough to help you sleep
- •
- reduces swelling of nasal passages
- •
- promotes nasal and/or sinus drainage
- •
- temporarily restores freer breathing through the nose
-
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.
- •
- to make child sleepy
Ask a doctor or pharmacist before use if you are
- •
- taking sedatives or tranquilizers
- •
- taking the blood thinning drug warfarin.
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Active ingredients (in each 15 mL) - Day Time
- Purpose
-
Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- sinus congestion and pressure
- •
- cough due to minor throat and bronchial irritation
- •
- minor aches and 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 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.
- Directions
- Other information
- Inactive ingredients
-
Package/Label Principal Display Panel
VALUE PACK
*Compare to the active ingredients in Vicks® Dayquil™ Severe cold & Flu Honey Flavor
DayTime
Cold & Flu
Relief
Acetaminophen - Pain reliever / Fever reducer
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal decongestant
Dextromethorphan HBr - Cough supressant
- •
- Headache, Fever, sore Throat, Minor Aches & Pains
- •
- Chest Congestion Thins & Loosen Mucus
- •
- Nasal Congestion & Sinus Pressure
- •
- Cough
Honey Flavor
Naturally and Artificially Flavored
TWO BOTTLES, 12 FL OZ (354 mL)
**Compare to the active ingredients in Vicks® Nyquil™ Severe cold & Flu Honey Flavor
Nighttime
Cold & Flu
Relief
Acetaminophen - Pain reliever / Fever reducer
Phenylephrine HCl - Nasal decongestant
Doxylamine succinate - Antihistamine
Dextromethorphan HBr - Cough supressant
For Relief of
- •
- Headache, Fever, Sore Throat, Minor Aches & Pains,
- •
- Nasal Congestion & Sinus Pressure
- •
- Sneezing, Runny Nose
- •
- Cough
Honey Flavor
Naturally and Artificially Flavored
Each; TOTAL 24 FL OZ (708 mL)
-
INGREDIENTS AND APPEARANCE
WALGREEN DAY TIME NIGHTTIME COLD AND FLU RELIEF HONEY FLAVOR
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride,guaifenesin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-6120 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-6120-24 1 in 1 PACKAGE; Type 0: Not a Combination Product 02/22/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 354 mL Part 2 1 BOTTLE 354 mL Part 1 of 2 WALGREEN NIGHTTIME COLD AND FLU RELIEF HONEY FLAVOR
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride solutionProduct Information 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 DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color BROWN Score Shape Size Flavor HONEY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 354 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 02/22/2021 Part 2 of 2 WALGREEN DAYTIME COLD AND FLU RELIEF HONEY FLAVOR
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solutionProduct Information 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color BROWN Score Shape Size Flavor HONEY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 354 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 02/22/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/22/2021 Labeler - WALGREENS CO. (008965063)
