MYGRIN NIGHTTIME (ACETAMINOPHEN, ASPIRIN (NSAID), AND DIPHENHYDRAMINE CITRATE) TABLET, FILM COATED [SUNASCEN THERAPEUTICS LLC]

MYGRIN NIGHTTIME (ACETAMINOPHEN, ASPIRIN (NSAID), AND DIPHENHYDRAMINE CITRATE) TABLET, FILM COATED [SUNASCEN THERAPEUTICS LLC]
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NDC 49467-230-10
Set ID f03f43af-4db8-4b61-8371-6b6d8ce71712
Category HUMAN OTC DRUG LABEL
Packager Sunascen Therapeutics LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENTS (In each caplet)

    Acetaminophen 250 mg
    Aspirin 250 mg (NSAID)*
    Diphenhydramine citrate 38 mg
    *NonSteroidal Anti-Inflammatory Drug

  • PURPOSE

    Pain reliever
    Pain reliever
    Nighttime sleep-aid

  • INDICATIONS AND USAGE

    For the temporary relief of occasional headaches, and minor aches and pains, with accompanying sleeplessness

  • WARNINGS

    Reye's Syndrome

    Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy Alert (Aspirin)

    Aspirin may cause a severe allergic reaction, which may include the following,

    • Hives
    • Facial swelling
    • Shock
    • Asthma (Wheezing)

    Allergy Alert (Acetaminophen)

    Acetaminophen may cause severe skin reactions. Symptoms may include the following,

    • Blisters
    • Rash
    • Skin reddening

    If a skin reaction does occur, stop use and seek medical help right away.

    Liver Warning

    This product contains acetaminophen. Severe liver damage may occur if you take the following,

    • More than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount
    • With other drugs containing acetaminophen
    • Three or more alcoholic drinks every day while using this product

    Stomach Bleeding Warning

    This product contains an NSAID, which may cause severe stomach bleeding. The chance of severe stomach bleeding is higher if you

    • Are age 60 or older
    • Have 3 or more alcoholic drinks every day while using this product
    • Take more than directed, or for a longer time than directed
    • Take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen or others]
    • Have had stomach ulcers or bleeding problems
    • Take a blood thinning (anticoagulant) or steroid drug

    Do Not Use

    Do not use this product in the following scenarios,

    • If you ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
    • With any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • With other products containing diphenhydramine, including any used externally
    • In children under 12 years of age

    Ask a Doctor

    Ask a doctor before using this product if,

    • The stomach bleeding warning applies to you
    • You have a history of stomach problems, such as heartburn
    • You have difficulty in urination due to enlargement of the prostate gland
    • You have liver disease
    • You have high blood pressure, heart disease, liver cirrhosis or kidney disease
    • You have glaucoma
    • You are taking a diuretic
    • You have asthma
    • You have a breathing problem such as emphysema or chronic bronchitis

    Ask a Doctor or a Pharmacist

    Ask a doctor or pharmacist before using this product if you are taking the following,

    • A prescription drug for:
      + Arthritis
      + Diabetes
      + Gout
    • Sedatives or Tranquilizers
    • Any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
    • Any other drug, or are under a doctor's care for any serious condition

    When using this product,

    • Do not drive a motor vehicle or operate machinery
    • Drowsiness may occur
    • Avoid alcoholic beverages

    Stop Use and ask a Doctor

    Stop use of this product and ask a Doctor in the event of the following,

    • If an allergic reaction occurs. Seek medical help right away.
    • You experience any of signs of stomach bleeding, such as
      + Feeling faint
      + Vomit blood
      + Have bloody or black stools
      + Have stomach pain that does not get better
    • New symptoms occur
    • Redness or swelling is present
    • Ringing in the ears or loss of hearing occurs
    • Your pain gets worse or lasts for more than 10 days
    • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

    These could be signs of a serious condition

    Pregnancy and Nursing Mothers

    If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children

    In case of an overdose, seek medical help right away or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE AND ADMINISTRATION (Directions)

    Adults and children 12 years of age and over: take up to 2 caplets at bedtime, with a full glass of water.

    • Do not take more than directed
    • Do not take more than 2 caplets in 24 hours, unless directed by a doctor
    • Do not use in children under 12 years of age
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of an overdose, seek medical help right away or contact a Poison Control Center immediately.
    Call Poison Control at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • STORAGE AND HANDLING

    • Store at 25ºC (77ºF); Excursions permitted between 15º-30ºC (59º-86ºF)
    • See end flap for expiration date and lot number
  • INACTIVE INGREDIENTS

    Corn Starch, Crospovidone, FD&C Blue #1 Aluminum Lake, Hypromellose, Maltodextrin, Medium Chain Triglycerides, Microcrystalline Cellulose, Polydextrose, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Sodium Sulfate, Stearic Acid, Talc, Titanium Dioxide, Yellow Iron Oxide, Zinc Stearate.

  • QUESTIONS OR COMMENTS?

    Sunascen Therapeutics LLC
    Call us toll free at 1-833-SUNASCN (786-2726) Mon-Fri 9am-5pm EST.
    Email us at ConsumerCare@Sunascen.com
    More information is available on our website at www.sunascen.com

  • PRINCIPAL DISPLAY PANEL

    Sunascen Therapeutics LLC

    NDC 49467-230-10

    MYGRIN NIGHTTIME
    ACETAMINOPHEN, 250 mg
    ASPIRIN (NSAID), 250 mg
    DIPHENHYDRAMINE CITRATE, 38 mg

    Pain Reliever and Sleep-Aid
    Non-habit forming

    "Helping you turn the face of pain into a grin" ™

    100 CAPLETS

    TAMPER EVIDENT: DO NOT USE IF THE SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Distributed by: Sunascen Therapeutics LLC, Rockville MD 20850
    © 2018 Sunascen Therapeutics LLC, All rights reserved.
    Trademarks are owned by or licensed to Sunascen Therapeutics LLC

    Sunascen Therapeutics LLC
    Quality Guaranteed
    Please Recycle
    ST230

    49467-230-10

  • INGREDIENTS AND APPEARANCE
    MYGRIN NIGHTTIME 
    acetaminophen, aspirin (nsaid), and diphenhydramine citrate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49467-230
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE38 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    Product Characteristics
    ColorTURQUOISEScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code ST230
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49467-230-101 in 1 CARTON02/05/2018
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/05/2018
    Labeler - Sunascen Therapeutics LLC (078272834)
    Registrant - Sunascen Therapeutics LLC (078272834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sunascen Therapeutics LLC078272834label(49467-230)

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