Home > Pill Identifier > APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet

Pill Identifier Information of APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet

Drug Information

APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet

Imprint:
Shape: C48348
Color: C48325
Ingredients: Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine
Size: 12.00
Score: 2
Rxtty: SY
Author: Eagle Distributors,Inc.
Inactive Ingredients: SILICON DIOXIDE / SODIUM LAURYL SULFATE / EDETATE DISODIUM / BIS(1-METHYLAMYL) SODIUM SULFOSUCCINATE / STARCH, CORN / POVIDONE K90 / GELATIN / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE / POLYETHYLENE GLYCOL 6000 / SODIUM BENZOATE / SODIUM STARCH GLYCOLATE TYPE A CORN / STEARIC ACID / TALC / D&C YELLOW No. 10 / ALUMINUM OXIDE / TITANIUM DIOXIDE>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Acetaminophen 325mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200mg

    Phenylephrine HCl 5mg

  • Purpose

    Pain reliever/ fever reducer

    Cough Suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • for the temporary relief of the following cold symptoms:
      • minor aches and pains
      • headache
      • sore throat
      • nasal congestion
      • cough
      • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • Warnings

    • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 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.
    • 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
    • a persistent 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

    When using this product do not exceed recommended dosage

    Stop use and ask a doctor if

    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 Center right away. Prompt 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 tablets with water every 6-8 hours as needed
    • Do not take more than 8 tablets in 24 hour
    Children under 12 years of ageConsult a doctor
  • Other Information

  • Inactive ingredients

    Colloidal silicon dioxide, Sodium Lauryl Sulphate, Edetaet disodium, dioctyl sodium sulphosuccinate, polyvinyl pyrollidone, gelatin, corn starch', magnesium Stearate, microcrystalline cellulose, polyethylene glycol 6000,Sodium Benzoate ,Sodium Starch Glycolate, Stearic acid, Purified Talc, D & C yellow #10 aluminium lake ,Titanium Dioxide.

  • SPL UNCLASSIFIED SECTION

    Product manufactured for:
    Eagle Distributors, Inc.
    Los Angeles, CA 90011

  • PRINCIPAL DISPLAY PANEL - 50 Pouch Carton

    NDC: 68737-227-11

    Compare to the Active Ingredients in
    Tylenol ® Cold
    Head Congestion*

    ConRx
    COLD
    SEVERE Sore throat -Cough - Headache

    TO OPEN
    PUSH IN TAB AND PULL OUT

    Compare to the Active Ingredients in
    Tylenol    ®Cold
    Head Congestion*

    50 Pouches of 2 Caplets Each

    Principal Display Panel - 50 Pouch Carton
  • INGREDIENTS AND APPEARANCE
    CONRX   COLD
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68737-227
    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) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BIS(1-METHYLAMYL) SODIUM SULFOSUCCINATE (UNII: 772Y8KZU65)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    D&C YELLOW No. 10 (UNII: 35SW5USQ3G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68737-227-1150 in 1 BOX
    12 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/10/2012
    Labeler - Eagle Distributors,Inc. (929837425)