Home > Pill Identifier > APAP 325 MG / Dextromethorphan Hydrobromide 15 MG / Guaifenesin 200 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet

Pill Identifier Information of APAP 325 MG / Dextromethorphan Hydrobromide 15 MG / Guaifenesin 200 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet

Drug Information

APAP 325 MG / Dextromethorphan Hydrobromide 15 MG / Guaifenesin 200 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet

Imprint: FR12
Shape: C48348
Color: C48325
Ingredients: Acetaminophen; Dextromethorphan; Guaifenesin; Pseudoephedrine
Size: 12.00
Score: 1
Rxtty: SY
Author: Select Corporation
Inactive Ingredients: MALTODEXTRIN / STARCH, CORN / STEARIC ACID / SODIUM STARCH GLYCOLATE TYPE A POTATO / POVIDONE K29/32 / CELLULOSE, MICROCRYSTALLINE>

Complete Information

  • ACTIVE INGREDIENT

    Active Ingredients

    Acetaminophen 325 mg.Guaifenesin 200 mg Phenylephrine HCl 5 mg


  • PURPOSE

    Pain Reliever, Fever Reducer, Expectorant, Nasal Decongestant, Cough Suppressant

  • DOSAGE & ADMINISTRATION

    Directions: adults and children 12 years of age and over • take 2 tablets with water every 6-8 hours, as needed • do not take more than 8 tablets in 24 hours children under 12 years of age • do not give to children under 12 years of age

  • INDICATIONS & USAGE

    Uses: or the temporary relief of the following cold symptoms: • minor aches and pains • headache • sore throat • nasal congestion • cough • helps loose phlegm (mucus) and thin bronchial secretions to make coughs more  productive • temporarily reduces fever

  • WARNINGS

    Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount, for this product • 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. • with any other product containing any of the above active ingredients • 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 • taking sedatives or tranquilizers When
    using this product • do not exceed recommended dosage • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives and tranquilizers may increase the drowsiness effect • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • nervousness, dizziness,or sleeplessness occur • pain or 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.
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid

  • PRINCIPAL DISPLAY PANEL

    MM1

    cold relief severe packet

  • INGREDIENTS AND APPEARANCE
    COLD RELIEF SEVERE PAIN COUGH  
    acetaminophen,guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-456
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (snow white) Scoreno score
    ShapeROUND (FR12) Size12mm
    FlavorImprint Code FR12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-456-022 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/15/2012
    Labeler - Select Corporation (053805599)