PAIN RELIEF REGULAR STRENGTH (ACETAMINOPHEN 325 MG) TABLET [ALLEGIANT HEALTH]

  • Home
  • PAIN RELIEF REGULAR STRENGTH (ACETAMINOPHEN 325 MG) TABLET [ALLEGIANT HEALTH]

PAIN RELIEF REGULAR STRENGTH (ACETAMINOPHEN 325 MG) TABLET [ALLEGIANT HEALTH]
PDF | XML
NDC 69168-234-60
Set ID 95bf4cc7-1dd6-4151-be10-eeb6ca80653e
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class
Product Number
Application Number PART343
View All Sections
  • Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporary relief of minor aches and pains associated with   

    ■ headache

    ■ backache  

    ■ muscular aches

    ■ minor pain of arthritis

    ■ the common cold

    ■ toothache  

    ■ premenstrual and menstrual cramps

    ■ temporarily reduces fever

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if   

    ■ adult takes more than 4,000 mg in 24 hours   

    ■ child takes more than 5 doses in 24 hours  

    ■ taken with other drugs containing acetaminophen  

    ■ adult has 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

    ■ if you are allergic to acetaminophen 

    ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

    Ask a doctor before use if you have

    liver disease

    Ask doctor/pharmacist before use if you

    are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    symptoms do not improve pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present ■ a rare sensitivity reaction occursYou may report side effects to 1-888-952-0050

    if pregnant or breast feeding

    ask a health professional before use

    Ask a doctor before use if user has

    liver disease.

    Ask a doctor or pharmacist before use if

    the user is taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    ■ symptoms do not improve  

    ■ pain gets worse or lasts for more than 10 days

    ■ pain gets worse or lasts for more than 5 days in children under 12 years  

    ■ fever gets worse or lasts for more than 3 days  

    ■ new symptoms occur  

    ■ redness or swelling is present  

    ■ a rare sensitivity reaction occurs  

    ■ You may report side effects to 800-852-0050

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.

  • Directions

    Adults and children 12 years of age and older: take 2 tablets every 4-6 hours. Do not take more than 10 tablets in 24 hours

    Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed. Do not take more than 5 tablets (1,625mg) in 24 hours

    Children under 6 years of age: Do not use this regular strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

  • Other information

    ■ store at room temperature
    ■ do not use if imprinted safety seal under cap is broken or missing

  • Inactive Ingredients

    corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • Package/Label Principal Display Panel

     RS Pain Relief

    RS Pain Relief

    RS Pain Relief

    RS Pain Relief

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF REGULAR STRENGTH 
    acetaminophen 325 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-234
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code AZ234
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-234-6060 in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/16/2014
    Labeler - Allegiant Health (079501930)
View All Sections

Related Drugs

Search DailyMed Drugs