Label: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE kit

  • NDC Code(s): 51316-604-05, 51316-605-05, 51316-609-07
  • Packager: CVS Pharmacy, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 3, 2024

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

  • Day Time Powder

    Drug Facts

    Active ingredients (in each packet)
    Acetaminophen 1000 mg
    Dextromethorphan HBr 30 mg

    Purposes

    Pain reliever/fever reducer
    Cough suppressant

    Uses

    • temporarily relieves these symptoms due to a common cold or flu:
    • minor aches and pains • minor sore throat pain • headache
    • cough due to minor throat and bronchial irritation
    • temporarily reduces fever

    Liver warning: This product contains 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 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.

    • in a child under 12 years of age

    • if you are allergic to acetaminophen
    • 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

    • a breathing problem such as emphysema or chronic bronchitis

    • cough that occurs with too much phlegm (mucus)

    • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

    Ask a doctor or pharmacist before use if you are
    • taking the blood thinning drug warfarin

    When using this product do not use more than directed.

    Stop use and ask a doctor if
    • 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 a rash or headache that lasts
    These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a doctor before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is
    critical for adults as well as for children even if you do not notice any signs or symptoms.

    Directions

    • do not use more than directed
    • take every 6 hours, while symptoms persist
    • Do not take more than 4 packets in 24 hours unless directed by a doctor
    • dissolve contents of one packet into 8 oz. hot water, sip while hot. Consume entire drink within 10 - 15 minutes.

    • if using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.

    AgeDose
    adults and children 12 years
    of age and over
    one packet
    children under 12 years of agedo not use

    Other information

    each packet contains: sodium 6 mg, potassium 10 mg
    • Store in a dry place at 15° – 30°C (59° – 86°F).

    acacia, acesulfame potassium, anhydrous citric acid, corn starch, D&C yellow #10, diacetyl tartaric and fatty acid esters of glycerol, FD&C blue #1, FD&C red #40, maltodextrin, medium chain triglycerides, natural flavor, propylene glycol, silicon dioxide, soy lecithin,
    sucralose, sucrose, tartaric acid, triacetin, tribasic calcium phosphate, trisodium citrate dihydrate, yeast.

  • Nighttime Powder

    Drug Facts

    Active ingredients (in each packet)
    Acetaminophen 1000 mg
    Chlorpheniramine maleate 4 mg
    Dextromethorphan HBr 30 mg

    Purposes
    Pain reliever/Fever reducer
    Antihistamine
    Cough suppressant

    Uses

    • temporarily relieves these symptoms due to a common cold or flu:
    • minor aches and pains • minor sore throat pain
    • headache • runny nose • cough due to minor throat and bronchial irritation
    • temporarily reduces fever

    Liver warning: This product contains 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 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

    • in a child under 12 years of age

    • if you are allergic to acetaminophen

    • 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

    • trouble urinating due to an enlarged prostate gland

    • a breathing problem such as emphysema or chronic bronchitis

    • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

    Ask a doctor or pharmacist before use if you are
    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product
    do not exceed recommended dosage

    • avoid alcoholic drinks

    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness

    • be careful when driving a motor vehicle or operating machinery

    • excitability may occur, especially in children

    Stop use and ask a doctor if
    • 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 a rash or headache that lasts

    These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a doctor before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Directions

    • do not use more than directed
    • take every 6 hours, while symptoms persist
    • Do not take more than 4 packets in 24 hours unless directed by a doctor

    • dissolve contents of one packet into 8 oz. hot water, sip while hot. Consume entire drink within 10 - 15 minutes.
    • if using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.

    AgeDose
    adults and children 12 years
    of age and over
    one packet
    children under 12 years of agedo not use

    Other information

    • each packet contains: sodium 6 mg, potassium 10 mg
    • Store in a dry place at 15° – 30°C (59° – 86°F).

    acacia, acesulfame potassium, anhydrous citric acid, corn starch, D&C yellow #10, diacetyl tartaric and fatty acid esters of glycerol, FD&C red #40, maltodextrin, medium chain triglycerides, natural flavor, propylene glycol, silicon dioxide, soy lecithin, sucralose, sucrose, tartaric acid, triacetin, tribasic calcium phosphate, trisodium citrate dihydrate, yeast.

  • QUESTIONS

    Questions? 1-800-231-4670

  • Draft Label

    CVS Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE 
    acetaminophen, dextromethorphan hbr, chlorpheniramine maleate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-609
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-609-071 in 1 CARTON; Type 1: Convenience Kit of Co-Package04/05/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 6   in 12 
    Part 21 PACKET 6   in 12 
    Part 1 of 2
    ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hbr powder
    Product Information
    Item Code (Source)NDC:51316-605
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL (UNII: 248HN3Z28U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    YEAST (UNII: 3NY3SM6B8U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TARTARIC ACID (UNII: W4888I119H)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    ACACIA (UNII: 5C5403N26O)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRIACETIN (UNII: XHX3C3X673)  
    SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
    Product Characteristics
    Coloryellow (Light Yellow) Score    
    ShapeSize
    FlavorHONEY (Honey Lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-605-056 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/05/2024
    Part 2 of 2
    ACETAMINOPHEN, DEXTROMETHORPHAN HBR 
    acetaminophen, dextromethorphan hbr powder
    Product Information
    Item Code (Source)NDC:51316-604
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL (UNII: 248HN3Z28U)  
    YEAST (UNII: 3NY3SM6B8U)  
    SUCROSE (UNII: C151H8M554)  
    TRIACETIN (UNII: XHX3C3X673)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ACACIA (UNII: 5C5403N26O)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TARTARIC ACID (UNII: W4888I119H)  
    Product Characteristics
    Coloryellow (Light yellow) Score    
    ShapeSize
    FlavorHONEY (Honey Lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-604-056 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/05/2024
    Labeler - CVS Pharmacy, Inc (062312574)