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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 1, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • 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
    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)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    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 finalpart34102/20/2014
    Labeler - Pharmadel LLC (030129680)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!