Label: ACETAMAX PM- acetaminophen,diphenhydramine hcl tablet, effervescent

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 31, 2020

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

  • Active Ingredients

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

  • Purpose

    • Fever Reducer/Pain Reliever
    • Nighttime sleep aid
  • Uses

    • temporary relief of 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 4,000 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 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
    • in children under 12 years of age
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have
    • a sodium-restricted diet.
    • 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
    • avoid alcoholic drinks
    • do not drive a motor vehicle or operate machinery

    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 lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • These could be signs of a serious condition.

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


    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Keep out of reach of children.

  • Directions


    Do not take more than directed (see overdose warning)
    Adults and children 12 years and over:
    • take 2 tablets fully dissolved in 8oz of water at  bedtime.
    • do not take more than 2 tablets of this product in 24 hours

    Children under 12 years: do not use

  • Other information


    Each tablet contains:
    Sodium 192 mg
    Store at room temperature 68 F-77 F (20oC-25oC)

  • Inactive Ingredients

    anhydrous citric acid, dimethicone, flavors, mannitol, polyethylene glycol 6000, polysorbate 20, povidone K30, silicon dioxide, sodium bicarbonate, sodium carbonate, sodium citrate, sucralose

  • SPL UNCLASSIFIED SECTION

  • Image

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  • INGREDIENTS AND APPEARANCE
    ACETAMAX PM 
    acetaminophen,diphenhydramine hcl tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-855
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize22mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13411-855-1616 in 1 BOX08/31/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:13411-855-2020 in 1 BOX08/31/2020
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:13411-855-2424 in 1 BOX08/31/2020
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/31/2020
    Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279)
    Establishment
    NameAddressID/FEIBusiness Operations
    S.P.M CORPORATION555279715manufacture(13411-855)