Home > Drugs A-Z > Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride (AAA Pharmaceutical, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 2 BLISTER PACK in 1 CARTON (57344-138-02) > 12 TABLET, COATED in 1 BLISTER PACK Label Information
TABLET, COATED 2 BLISTER PACK in 1 CARTON (57344-138-05) > 12 TABLET, COATED in 1 BLISTER PACK Label Information

Complete Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) Purpose
    Acetaminophen 325 mg Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg Cough suppressant
    Phenylephrine HCl 5 mg Nasal decongestant

  • Uses

    • temporarily relieves these common cold/flu symptoms:
      • minor aches and pains
      • headache
      • sore throat
      • nasal congestion
      • cough
      • sinus congestion and pressure
    • helps clear nasal passages
    • promotes nasal and sinus drainage
    • temporarily reduces fever

  • Warnings

    Liver warning

    This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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

    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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have
    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • 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)

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

    When using this product do not exceed recommended dosage

    Stop use and ask a doctor if
    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, 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 or headache that lasts

    These could be signs of a serious condition.

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

    Keep out of reach of children.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away (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

    adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole – do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
    children under 12 years
    • ask a doctor

  • Other information

    • store between 20-25°C (68-77°F) in a dry place
    • retain carton for complete product information

  • Inactive ingredients

    acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide


  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048


  • PRINCIPAL DISPLAY PANEL - 24 Caplet Blist Pack Carton

    RESTORE u

    NDC 57344-138-05

    †COMPARE TO THE ACTIVE
    INGREDIENTS IN TYLENOL® COLD
    MULTI-SYMPTOM - DAYTIME

    See New Warnings
    Information & Directions

    DAYTIME
    NON-DROWSY

    Cold
    For
    Adults
    MULTI-SYMPTOM

    Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant

    • Headache/Fever/Sore Throat – Acetaminophen
    • Nasal Congestion – Phenylephrine HCl
    • Coughing – Dextromethorphan HBr

    24 CAPLETS

    Principal Display Panel - 24 Caplet Blist Pack Carton

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-138
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 17mm
    Flavor MINT Imprint Code AAA;1138
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-138-02 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    2 NDC:57344-138-05 2 in 1 CARTON
    2 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/28/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)