Label: DAYTIME NIGHTTIME COLD FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients for Daytime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • ACTIVE INGREDIENT

    Active ingredients for Nighttime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg

  • PURPOSE

    Purposes

    for Daytime

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • PURPOSE

    Purposes

    for Nighttime

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    Daytime

    • temporarily relieves common cold and flu symptoms
    • cough due to minor throat and bronchial irritation
    • nasal congestion
    • headache
    • minor aches and pains
    • Fever
    • sore throat

    Uses

    Nighttime

    • temporarily relieves common cold and flu symptoms
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing
  • WARNINGS

    Warnings

    Daytime

    Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this products

    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.

    Nighttime

    Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this products

    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

    • 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.

    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 contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    Daytime

    • liver disease
    • heart disease
    • diabetes
    • thyroid disease
    • high blood pressure
    • cough that occurs with too much phlegm (mucus)
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

    Nighttime

    • liver disease
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    Daytime

    taking the blood thinning drug warfarin

    Nighttime

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    Daytime

    do not exceed recommended dosage

    Nighttime

    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    Daytime

    • nervousness, dizziness or sleeplessness occur
    • pain, cough, and nasal congestion 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.

    Nighttime

    • pain 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 headache that lasts.

    These could be a signs of a serious condition

    If pregnant or breast-feeding,

    ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    Overdose warning:

    Taking more than the recommended dose can 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 adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    Daytime

    • do not take more than directed (see Overdose warning)
    • do not take more than 4 doses in 24 hours
    • swallow whole; do not crush, chew, or dissolve

    adults and children 12 years and over: take 2 softgels with water every 4 hours.

    children under 12 years: do not use

    Nighttime

    • do not take more than directed (see Overdose warning)
    • do not take more than 4 doses in 24 hours
    • swallow whole; do not crush, chew, or dissolve

    adults and children 12 years and over: take 2 softgels with water every 6 hours

    children under 12 years: do not use

  • STORAGE AND HANDLING

    Other information

    • store between 15-30°C (59-86°F)
    • avoid excessive heat
  • INACTIVE INGREDIENT

    Inactive ingredients

    Daytime

    Gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, FD&C yellow #6, FD&C Red #40 , white ink

    Nighttime

    D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

  • QUESTIONS

    Questions or comments?

    Call 1-855-642-2594

  • PRINCIPAL DISPLAY PANEL

    †Compare to the active ingredients in Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps®

    Daytime

    NDC 24689-152-01

    Multi-Symptom Cold & Flu Relief

    Acetaminophen 325 mg- Pain reliever / Fever reducer

    Dextromethorphan HBr 10 mg - Cough suppressant

    Phenylephrine HCI 5 mg - Nasal decongestant

    Relieves:

    • Aches, fever, sore throat
    • Cough
    • Nasal congestion

    Non-drowsy

    Alcohol-Free

    Antihistamine-Free

    Softgels**

    (** Liquid-filled capsules)

    Nighttime

    Multi-Symptom Cold & Flu Relief

    Acetaminophen 325 mg - Pain reliever / Fever reducer

    Dextromethorphan HBr 15 mg - Cough suppressant

    Doxylamine succinate 6.25 mg - Antihistamine

    Relieves:

    • Aches, fever, sore throat
    • Cough
    • Runny nose, sneezing

    Softgels**

    Alcohol-free

    (**Liquid-filled capsules)

    When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.

    †This product is not manufactured or distributed by The Procter & Gamble Company.

    Vicks®, DayQuil®, NyQuil®, and LiquiCaps® are registered trademarks of the Procter and Gamble Company.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Distributed by:

    APNAR PHARMA LP

    CHINO, CA, USA, 91710

    Rev.: 04/2023

    Daytime and Nighttime Soft Gel-Carton-label

  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME COLD FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-152
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24689-152-011 in 1 CARTON; Type 0: Not a Combination Product05/11/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 116 BLISTER PACK 16 
    Part 232 BLISTER PACK 32 
    Part 1 of 2
    NIGHTTIME COLD FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate capsule
    Product Information
    Item Code (Source)NDC:24689-157
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN (UNII: 6O92ICV9RU)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize23mm
    FlavorImprint Code AA7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/11/2023
    Part 2 of 2
    DAYTIME COLD FLU RELIEF 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule
    Product Information
    Item Code (Source)NDC:24689-158
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN (UNII: 6O92ICV9RU)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize23mm
    FlavorImprint Code AA6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    132 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/11/2023
    Labeler - APNAR PHARMA LP (079568229)
    Establishment
    NameAddressID/FEIBusiness Operations
    APNAR PHARMA LLP118530917manufacture(24689-152) , analysis(24689-152)