Label: PERCOGESIC ORIGINAL STRENGTH- acetaminophen and diphenhydramine hcl tablet, coated

  • NDC Code(s): 63029-053-24, 63029-053-50, 63029-053-90
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each tablet)

    Acetaminophen 325 mg

  • Purpose

    Pain reliever/fever reducer

  • Active Ingredients (in each tablet)

    Diphenhydramine HCl 12.5 mg

  • Purpose

    Antihistamine

  • Uses

    for temporary relief of minor aches and pains due to:

    • headache
    • backache
    • muscular aches
    • arthritis pain
    • colds
    • flu
    • fever
    • toothache
    • premenstrual and menstrual cramps

    Temporarily relieves

    • runny nose
    • sneezing
    • itchy nose and throat
  • Warnings

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

    • more than 8 tablets 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.

    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
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor or pharmacist 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

    • marked drowsiness may occur
    • avoid alcoholic beverages  
    • alcohol, sedatives, and tranquilizers may cause drowsiness
    • may cause excitability, especially in children
    • be careful driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • pain persists for more than 10 days
    • fever persists for more than 3 days (unless directed by a doctor)  
    • condition worsens or new symptoms occur
    • redness or swelling is present. These may be signs of a serious condition.

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

    Keep out of the reach of children.

  • Overdose warning:

    Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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. Adults and children 12 years and older: take 2 tablets every 4-6 hours. Maximum daily dose is 8 tablets.

    Children under 12 years of age:  ask a doctor

  • Other Information  

    • store at controlled room temperature 15°-30°C (59°-86°F)  
    • avoid excessive heat
  • Inactive Ingredients

    Croscarmellose Sodium, FD&C Yellow #6 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Pregelatinized Starch, Silica, Sodium Starch Glycolate and Stearic Acid

  • Questions?

    1-800-443-4908

  • PRINCIPAL DISPLAY PANEL

    ORIGINAL STRENGTH
    Percogesic®
    Acetaminophen/Diphenhydramine     HCl

    Aspirin-Free, Pain Reliever,
    Fever Reducer/ Antihistamine

    50 COATED TABLETS

    PRINCIPAL DISPLAY PANEL FAST ACTING ORIGINAL STRENGTH Percogesic® Acetaminophen/Diphenhydramine for ENCHANCED RELIEF of PAIN Aspirin-Free, Pain Reliever, Fever Reducer/ Antihistamine See new warnings information. 90 EASY TO SWALLOW COATED TABLETS

  • INGREDIENTS AND APPEARANCE
    PERCOGESIC  ORIGINAL STRENGTH
    acetaminophen and diphenhydramine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-053
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TALC (UNII: 7SEV7J4R1U)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code Percogesic
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-053-901 in 1 BOX03/19/2010
    190 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:63029-053-501 in 1 BOX03/19/2010
    250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:63029-053-241 in 1 BOX03/19/2010
    324 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/19/2010
    Labeler - Medtech Products Inc. (122715688)
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