PAMPRIN MAX MENSTRUAL PAIN RELIEF (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) TABLET, FILM COATED [FOCUS CONSUMER HEALTHCARE, LLC]

PAMPRIN MAX MENSTRUAL PAIN RELIEF (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) TABLET, FILM COATED [FOCUS CONSUMER HEALTHCARE, LLC]
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NDC 71687-3006-6
Set ID 5bd4b935-f003-7df8-e053-2a91aa0a5d79
Category HUMAN OTC DRUG LABEL
Packager Focus Consumer Healthcare, LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • PURPOSE

    Pain reliever

    Diuretic

    *nonsteroidal anti-inflammatory drug

  • ACTIVE INGREDIENT

    (in each caplet)

    Acetaminophen 250 mg

    Aspirin 250 mg

    Caffeine 65 mg

  • INACTIVE INGREDIENT

    D&C Red No. 27 Lake, FD&C Red No. 40 Lake, fractionated coconut oil, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide (245-171)

  • INDICATIONS & USAGE

    For the temporary relief of these symptoms associated with menstrual periods:

    • cramps
    • headache
    • backache
    • fatigue
    • bloating
  • 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 may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Allergy warning: 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.

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

    • more than 8 caplets 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

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

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

    Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer

    • 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
    • the stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic

    Ask a doctor or pharmacist before use

    if you are taking a prescription drug for gout, diabetes or arthritis

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • redness or swelling is present
    • new symptoms occur
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • ringing in the ears or loss of hearing occurs

    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 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.

  • SPL UNCLASSIFIED SECTION

    When using this product

    • you may get drowsy, avoid alcoholic beverages
    • alcohol sedatives and tranquilizers may increase drowsiness
    • use caution when driving or operating machinery
    • excitability may occur especially in children

    stop use and ask doctor if

    • 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

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Adults and children12 years and over:

    • take 2 caplets with water every 6 hours as needed

    • do not exceed 8 caplets in a 24 hour period or as directed by a doctor

    • do not use more than directed (see warnings)

    children under 12 years: ask a doctor

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PAMPRIN MAX MENSTRUAL PAIN RELIEF 
    acetaminophen and aspirin and caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71687-3006
    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
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorpink (FD & C Red No. 40) , pink (D&C REd No. 27) Scoreno score
    ShapeOVALSize17mm
    FlavorImprint Code MAX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71687-3006-61 in 1 CARTON10/18/2017
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/18/2017
    Labeler - Focus Consumer Healthcare, LLC (080743737)

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