SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC]

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  • SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC]

SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC]
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NDC 55758-010-01, 55758-010-06, 55758-010-18
Set ID b995a0b2-898d-4a8f-b44f-097ae54e0ba5
Category HUMAN OTC DRUG LABEL
Packager Pharmadel LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each packet)Purposes
    Acetaminophen 650 mgPain reliever/ fever reducer
    Dextromethorphan HBr 20 mgCough suppressant
    Phenylephrine HCI 10 mgNasal decongestant

  • Uses

    Temporarily relieves common cold/flu symptoms:

    • cough due to minor throat & bronchial irritation
    • headache
    • sore throat
    • minor aches & pains
    • nasal congestion due to hay fever
    • other upper respiratory allergies
    • sinus congestion and pressure
    • stuffy nose
    • reduces fever
  • 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

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away

    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 (MAOIs) (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.
    • for more than 7 days for pain and 3 days for fever, unless directed by a doctor

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • a cough that is accompanied by excessive phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking, asthma or emphysema
    • trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmacist before use if

    • taking the blood thinning drug warafin

    Stop use and ask a doctor if

    • a persistent cough or symptoms do not improve within 5 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
    • new symptoms occur
    • redness or swelling is present
    • nervousness, dizziness, or sleeplessness occur

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

    KEEP OUT OF REACH OF CHILDREN. In case of accidental 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.

  • Directions

    • do not exceed recommended dosage
    • take every 4 hours; do not exceed 6 packets in a 24-hour period
    • dissolve contents of one packet into 8 oz. of hot water and sip while hot; consume entire drink within 10-15 minutes
    • if using a microwave; add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.

    AgeDose
    adults & children 12 yrs. of age & overone packet every 4 hours
    children under 12 yrs. of agedo not use

  • Other information

    • each packet contains: potassium 10 mg, sodium 27 mg
    • phenylketonurics: contains phenylalanine 14 mg per packet
    • store at room temperature 68-77°F (20-25°C)
    • protect from excessive heat and moisture

    TAMPER EVIDENT: Do not use if packets are broken or torn.

  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue 1, FD&C red 40, flavors, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

  • Questions or Comments?

    1-866=359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

  • SPL UNCLASSIFIED SECTION

    Distributed by/ Distribuido por:
    PHARMADEL

    Georgetown, DE 19947

    Made in India

  • PRINCIPAL DISPLAY PANEL

    SanaTos ® Severe COLD & COUGH

    NDC 55758-010-01

    NDC 55758-010-06

    Box

  • INGREDIENTS AND APPEARANCE
    SANATOS SEVERE COLD AND COUGH DAY TIME 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-010-066 in 1 CARTON; Type 0: Not a Combination Product02/20/2014
    2NDC:55758-010-011 in 1 POUCH; Type 0: Not a Combination Product02/20/2014
    3NDC:55758-010-1818 in 1 CARTON; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/20/2014
    Labeler - Pharmadel LLC (030129680)
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