Label: DAYTIME NIGHTTIME COLD AND COUGH- acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate kit
- NDC Code(s): 0363-4670-24
- Packager: Walgreens
- 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 September 27, 2022
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) Daytime
- Active ingredients for (in each 30 mL) Nighttime
- Purposes for Day Time
- Purpose for Night Time
-
Uses
DAYTIME
- temporarily relieves common cold and flu symptoms
- minor aches and pains
- headache
- sore throat
- nasal congestion
- fever
- cough due to minor throat and bronchial irritation
NIGHTTIME
-
temporarily relieves common cold/flu symptoms
- minor aches and pain
- headache
- sore throat
- runny nose and sneezing
- fever
- cough due to minor throat and bronchial irritations as may occur with a cold
- temporarily relieves common cold and flu symptoms
-
Warnings
DAYTIME NIGHTTIME
Liver warning: This product contain acetaminophen. Severe liver damage may occur if:
- adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
- child takes more than 4 doses (15 mL each) in 24 hours
- taken 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
DAYTIME NIGHTTIME
- 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 contain an MAOI, ask a doctor or pharmacist before taking this product
Ask a doctor before use if have
DAYTIME
- liver disease
- high blood pressure
- heart disease
- thyroid disease
- diabetes
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
NIGHTTIME
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to enlarged prostate gland
- a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if the child is
DAYTIME
if you are taking the blood thinning drug warfarin
NIGHTTIME
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
DAYTIME
do not exceed recommended dosage.
NIGHTTIME
- excitability may occur, especially in children
- mark drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
DAYTIME
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult)
- 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.persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.
These could be signs of a serious condition.
NIGHTTIME
- pain or cough gets worse or lasts more than 7 days
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adult as well as for children even if you do not notice any signs or symptoms.
-
Directions
DAYTIME
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL= milliliter
adult and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use NIGHTTIME
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL= milliliter
- adult and children 12 years and over: 30 mL every 6 hours
- children under 12 years of age: do not use
- Other information
-
Inactive ingredients
DAYTIME
citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
NIGHTTIME
acesulfame potassium, alcohol, anhydrous citric acid, D&C yellow #10 FD&C green #3, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, trisodium citrate dihydrate
- Questions or comments?
-
Principal Display Panel
Compare to the active ingredients in Vick® Dayquil® Cold & Flu & Vick® Nyquil® Cold & Flu††
DAYTIME • NON-DROWSY
Cold & Cough
ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr 10 mg / COUGH SUPPRESSANT
PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT
Multi-Symptom
- Relieves aches, fever,& sore throat, cough & nasal congestion
- For ages 6 years & over
- Alcohol free
- Antihistamine free
FL OZ (mL)
NIGHTTIME
Cold & Flu
ACETAMINOPHEN 650 mg / PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr 30 mg / COUGH SUPPRESSANT
DOXYLAMINE SUCCINATE 12.5 mg / ANTIHISTAMINE
Multi-Symptom
- Relieves headache, fever, sore throat, minor aches & pains, sneezing, runny nose & cough
- For ages 12 years & over
- Nighttime relief
- ALCOHOL 10%
FL OZ (mL)
WHEN USING OTHER DAYTIME OR NIGHTTIME PRODUCTS, CAREFULLY READ EACH LABEL TO ENSURE CORRECT DOSING
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
††These products are not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil® and Nyquil® are registered trademarks of the Procter & Gamble Company.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
- Relieves aches, fever,& sore throat, cough & nasal congestion
- Product Label
-
INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME COLD AND COUGH
acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4670 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-4670-24 1 in 1 KIT; Type 0: Not a Combination Product 07/30/2020 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 RELIEF
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Item Code (Source) NDC:0363-4661 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 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) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 355 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 07/30/2020 Part 2 of 2 COLD AND FLU NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Item Code (Source) NDC:0363-3430 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ALCOHOL (UNII: 3K9958V90M) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 355 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 07/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/30/2020 Labeler - Walgreens (008965063)
