Label: SANATOS SEVERE COLD AND COUGH NIGHTTIME- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride granule, for solution

  • NDC Code(s): 55758-009-01, 55758-009-06, 55758-009-18
  • Packager: Pharmadel LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each packet)Purposes
    Acetaminophen 650 mgPain reliever/ fever reducer
    Diphenhydramine HCI 25 mgAntihistamine/ cough suppressant
    Phenylephrine HCI 10 mgNasal decongestant
  • Uses

    Temporarily relieves common cold/flu symptoms:

    • headache
    • sore throat
    • minor aches & pains
    • nasal congestion & itchy, watery eyes due to hay fever
    • other respiratory allergies
    • cough due to minor throat & bronchial irritation
    • itchy nose and throat
    • runny nose
    • sneezing
    • stuffy nose
    • and reduces fever
  • Warnings

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

    • more than 6 doses 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 (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.
    • for more than 7 days for pain and 3 days for fever, unless directed by a doctor
    • with any other product containing diphenhydramine, even one used on skin

    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
    • chronic bronchitis
    • trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • may cause excitability especially in children
    • may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages while taking this product
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask doctor if

    • new symptoms occur
    • pain or fever persists or gets worse
    • symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
    • if nervousness, dizziness, or sleeplessness occur

    If pregnant or breast-feeding, ask a health 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 take more than 6 packets in 24- hour period
    • dissolve contents of one packet into 8 oz. 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.

    Age Dose
    adults & children 12 years of age & overone packet every 4 hours
    children under 12 years of agedo not use
  • Other information

    • each packet contains: potassium 10 mg, sodium 27 mg
    • phenylketonurics: contains phenylalanine 13 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, D&C yellow 10, 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:

    PHARMADEL

    Georgetown, DE 19947

    Made in India

  • PRINCIPAL DISPLAY PANEL

    SanaTos ®Severe COLD & COUGH Nighttime

    NDC 55758-009-01

    NDC 55758-009-06

    Label

  • INGREDIENTS AND APPEARANCE
    SANATOS SEVERE COLD AND COUGH NIGHTTIME 
    acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorHONEY, LEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-009-066 in 1 CARTON; Type 0: Not a Combination Product02/20/2014
    2NDC:55758-009-011 in 1 POUCH; Type 0: Not a Combination Product02/20/2014
    3NDC:55758-009-1818 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 DrugM01202/20/2014
    Labeler - Pharmadel LLC (030129680)
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