Label: CAREALL NON-ASPIRIN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet

  • NDC Code(s): 51824-069-50
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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

  • Active Ingredients

    Acetaminophen 500mg

    Diphenhydramine HCl 25mg

  • Purpose

    Pain reliever

    Nightime sleep aid

  • Keep Out of reach of Children

    Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.  Quick Medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Uses

    Temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness

  • Warnings

    Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take
    • More than 4000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product.

    Allergy Alert:Acetaminophen may cause sever skin reactions.  Symptoms may include: skin reddening, blisters, rash.  If a skin reaction occurs, stop use and seek medical help right away.

    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.
    • with any other product containing diphenhydramine, even one used on skin
    • in children under 12 years of age
    • if you have even had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    • liver disease
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland
    • glaucoma

    Ask a doctor or pharmacist before use if you are

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

    When using this product

    •drowsiness will occur

    •do not drive a motor vehicle or operate machinery

    •avoid alcoholic drinks

    Stop use and ask a doctor if

    •sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

    •pain gets worse or last for more than 10 days.

    •fever gets worse or last for more than 3 days

    •redness or swelling are present

    •new symptoms occur.  These could be signs of a serious condition.

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

  • Directions

    Do not use more than directed.  (see overdose warning)

    Adults and children 12 years of age and older: Take 2 caplets at bedtime.  Do not take more than 2 caplets in 24 hours

    Children under 12 years: do not use

  • Inactive Ingredients

    Croscarmellose sodium, FD and C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide, Copovidone K25-31, Lactose, and Magnesium Sterate

  • PRINCIPAL DISPLAY PANEL

    PMC50024 Label
  • INGREDIENTS AND APPEARANCE
    CAREALL NON-ASPIRIN PM  EXTRA STRENGTH
    acetaminophen, diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-069
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code AAA;1031
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-069-5050 in 1 BOTTLE; Type 0: Not a Combination Product11/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/30/2018
    Labeler - New World Imports, Inc (075372276)