Label: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE- acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet, coated 

  • Label RSS
  • NDC Code(s): 57344-159-02
  • Packager: AAA Pharmaceutical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) Purpose
    Acetaminophen 325 mg Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg Cough suppressant
    Guaifenesin 200 mg Expectorant
    Phenylephrine HCl 5 mg Nasal decongestant
    Close
  • Uses

    • for the temporary relief of the following cold/flu symptoms:
      • minor aches and pains
      • headache
      • sore throat
      • nasal congestion
      • cough
      • impulse to cough
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily reduces fever
    Close
  • Warnings

    Liver warning

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

    • more than 12 caplets 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

    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.

    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, chronic bronchitis, 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

    Taking more than the recommended dose (overdose) may cause liver damage. 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.

    Close
  • 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 12 caplets in 24 hours
    children under 12 years
    • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
    Close
  • Other information

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

    acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #2, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

    Close
  • SPL UNCLASSIFIED SECTION

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

    Close
  • PRINCIPAL DISPLAY PANEL - 24 Caplet Carton

    RESTORE u

    NDC 57344-159-02

    †COMPARE TO THE ACTIVE
    INGREDIENTS IN TYLENOL®
    COLD HEAD CONGESTION
    SEVERE

    DAYTIME
    NON-DROWSY

    Severe Cold

    HEAD CONGESTION
    Pain Reliever/Fever Reducer, Nasal Decongestant,
    Cough Suppressant, Expectorant

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

    COOL TASTE

    24 CAPLETS

    Principal Display Panel - 24 Caplet Carton
    Close
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57344-159
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    CROSPOVIDONE  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 2  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    POVIDONES  
    STARCH, CORN  
    PROPYLENE GLYCOL  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color YELLOW Score no score
    Shape OVAL Size 19mm
    Flavor MINT Imprint Code AAA;1136
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-159-02 2 in 1 CARTON
    1 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)
    Close