Label: ALGIDOL FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit

  • NDC Code(s): 69377-003-01, 69377-004-01, 69377-005-01
  • Packager: Gelpharma S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 8, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredients (in each softgel capsule)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • temporarily relieves
    • minor aches and pains associated with the common cold, sore throat, or headache
    • cough associated with the common cold
    • nasal congestion due to the common cold
    • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • Warnings

    This product contains acetaminophen. Severe liver damage may occur if you take: Liver warning:

    Acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert:

    If a skin reaction occurs, stop use and seek medical help right away.

    • more than 8 capsules in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product
    • skin reddening
    • blisters
    • rash 

    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.
    • for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
    • if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

    Ask a doctor before use if 

    you have liver disease.

    Ask a doctor or pharmacist before use

    if you are taking the blood thinning drug warfarin.

    When using this product

    • do not exceed the recommended dosage
    • do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. If pain or fever persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.
    • 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.
    • if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

    Stop use and ask a doctor if

    • pain or nasal decongestion 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
    • if nervousness, dizziness, or sleeplessness occur

    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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed
    • do not exceed 8 capsules per 24 hours
     Adults & children 12 years & over 2 capsules with water every 4 hours
     Children 4 to under 12 years Consult a doctor
     Children under 4 years Do not use

  • Other information

    • do not exceed 77°F (25°C)
    • avoid excessive heat
  • Inactive ingredients

    gelatin, purified water, glycerin, polyethylene glycol 1000, propylene glycol, polyethylene glycol 600, povidone K30, orange flavor, FD&C Yellow No. 6, BHT, BHA.

  • Drug Facts

  • Active ingredients (in each softgel capsule)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCl 5 mg

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    • temporarily relieves
    • minor aches and pains associated with the common cold, sore throat, or headache
    • cough associated with the common cold
    • nasal congestion due to the common cold
    • runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever
    • temporarily reduces fever
  • Warnings

    This product contains acetaminophen. Severe liver damage may occur if you take: Liver warning:

    Acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert:

    If a skin reaction occurs, stop use and seek medical help right away.

    • more than 8 capsules in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product
    • skin reddening
    • blisters
    • rash

    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.
    • for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
    • if you have heart disease, high blood pressure, thyroid disease, diabetes, a breathing problem such as emphysema or chronic bronchitis, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

    Ask a doctor before use if

    you have liver disease.

    Ask a doctor or pharmacist before use if

    you are taking the blood thinning drug warfarin.

    When using this product

    • do not exceed the recommended dosage
    • do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. because these could be signs of a serious condition.
    • 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.
    • if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
    • may cause excitability especially in children
    • may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

    Stop use and ask a doctor if

    • pain or nasal decongestion 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
    • if nervousness, dizziness, or sleeplessness occur

    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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed
    • do not exceed 8 capsules per 24 hours
     Adults & children 12 years & over 2 capsules with water every 4 hours
     Children 4 to under 12 years Consult a doctor
     Children under 4 years Do not use

  • Other information

    • do not exceed 77°F (25°C)
    • avoid excessive heat
  • Inactive ingredients

    gelatin, purified water, polyethylene glycol 1000, glycerin, polyethylene glycol 600, propylene glycol, povidone K30, citric acid, mint flavor, FD&C Blue No. 1, FD&C Yellow No. 6, BHT, BHA.

  • Package Labeling:

    LabelInner Package

  • INGREDIENTS AND APPEARANCE
    ALGIDOL FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69377-003
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69377-003-011 in 1 CARTON09/01/2022
    11 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 CAPSULE
    Part 20 CAPSULE
    Part 1 of 2
    ALGIDOL DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule
    Product Information
    Item Code (Source)NDC:69377-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POVIDONE K30 (UNII: U725QWY32X)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69377-004-012 in 1 BLISTER PACK
    18 in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/01/2022
    Part 2 of 2
    ALGIDOL NIGHTTIME 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule
    Product Information
    Item Code (Source)NDC:69377-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE K30 (UNII: U725QWY32X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69377-005-011 in 1 BLISTER PACK
    18 in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/01/2022
    Labeler - Gelpharma S.A. de C.V. (812773665)