TOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]

TOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]
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NDC 36800-802-06
Set ID ef12626d-dc9e-4e07-9e97-6edf0ea82f9c
Category HUMAN OTC DRUG LABEL
Packager TOPCARE (Topco Associates LLC)
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Topcare Cold and Sore Throat Lemon Flavor

    Active Ingredients (in each packet)                               Purpose

    Acetaminophen 325 mg...................................Pain reliever/Fever reducer

    Pheniramine maleate 20 mg................................................Antihistamine

    Phenylephrine hydrochloride 10 mg.............................Nasal decongestant.

  • PURPOSE

    Uses
    - temporarily relieves these symptoms due to a cold:
        - minor aches and pains   - headache   - minor sore throat pain
        - nasal congestion   - temporarily reduces fever
    - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
        - runny nose   - sneezing   - itchy nose and throat   - itchy, watery eyes.

  • WARNINGS

    Warnings
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take   - more than 6 packets 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.
    Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

    Do not use   - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
    - 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 a MAOI, ask a doctor or pharmacist before taking this product.
    - with any other product containing acetaminophen (see Overdose Warning).

    Ask a doctor before use if you have
    - liver disease   - heart disease   - high blood pressure   - thyroid disease   - diabetes   - glaucoma   - a breathing problem such as emphysema, asthma, or chronic bronchitis   - trouble urinating due to an enlarged prostate gland   - a sodium-restricted diet.

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

    When using this product
    - do not exceed recommended dosage
    - avoid alcoholic drinks   - may cause drowsiness
    - alcohol, sedatives, and tranquilizers may increase drowsiness
    - be careful when driving a motor vehicle or operating machinery
    - excitability may occur, especially in children.

    Stop use and ask a doctor if
    - nervousness, dizziness, or sleeplessness occurs
    - pain or nasal congestion 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
    - sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting. These could be signs of a serious condition.

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

    Keep out of reach of children.

    Overdose Warning: Taking more than the recommended dose can cause serious health problems, including serious liver damage. 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 for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions
    - do not use more than directed (see Overdose Warning)
    - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor
    - adults and children 12 years of age and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
    - children under 12 years of age: consult a doctor
    - If using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

  • INFORMATION FOR PATIENTS

    Other Information
    - each packet contains: sodium 66 mg
    - store at controlled room temperature 20-25C (68-77F).

  • INACTIVE INGREDIENT

    Citric acid, D and C Yellow 10, Ethylcellulose, FD and C Red 40, Flavor, Microcrystalline cellulose, Povidone, Silicon Dioxide, Sodium Citrate, Starch, Sugar and Vitamin C.

  • PRINCIPAL DISPLAY PANEL

    MM1.jpg

  • INGREDIENTS AND APPEARANCE
    TOPCARE COLD AND SORE THROAT  LEMON FLAVOR
    acetaminophen, pheniramine maleate, phenylephrine hcl granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-802
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Pheniramine Maleate (UNII: NYW905655B) (Pheniramine - UNII:134FM9ZZ6M) Pheniramine Maleate20 mg
    Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride10 mg
    Inactive Ingredients
    Ingredient NameStrength
    Citric acid monohydrate (UNII: 2968PHW8QP)  
    Ethylcellulose (100 MPA.S) (UNII: 47MLB0F1MV)  
    Cellulose, microcrystalline (UNII: OP1R32D61U)  
    Povidone (UNII: FZ989GH94E)  
    Silicon dioxide (UNII: ETJ7Z6XBU4)  
    Sodium citrate (UNII: 1Q73Q2JULR)  
    Sucrose (UNII: C151H8M554)  
    Ascorbic acid (UNII: PQ6CK8PD0R)  
    Product Characteristics
    Coloryellow (D and C Yellow 10) , red (FD and C Red 40) Score    
    ShapeSize
    FlavorLEMON (Nature Lemon Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-802-066 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/20/2014
    Labeler - TOPCARE (Topco Associates LLC) (006935977)

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