{
    "spl_product_data_elements": [
        "Excedrin Extra Strength Acetaminophen, Aspirin, and Caffeine BENZOIC ACID CARNAUBA WAX FD&C BLUE NO. 1 HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED LIGHT MINERAL OIL MICROCRYSTALLINE CELLULOSE POLYSORBATE 20 POVIDONE, UNSPECIFIED PROPYLENE GLYCOL SORBITAN MONOLAURATE STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE Capsule-Shaped Tablet E White Excedrin Extra Strength, TRAVEL BASIX Acetaminophen, Aspirin, and Caffeine BENZOIC ACID CARNAUBA WAX FD&C BLUE NO. 1 HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED LIGHT MINERAL OIL MICROCRYSTALLINE CELLULOSE POLYSORBATE 20 POVIDONE, UNSPECIFIED PROPYLENE GLYCOL SORBITAN MONOLAURATE STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE Capsule-Shaped Tablet E White Excedrin Extra Strength, CVP HEALTH Acetaminophen, Aspirin, and Caffeine BENZOIC ACID CARNAUBA WAX FD&C BLUE NO. 1 HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED LIGHT MINERAL OIL MICROCRYSTALLINE CELLULOSE POLYSORBATE 20 POVIDONE, UNSPECIFIED PROPYLENE GLYCOL SORBITAN MONOLAURATE STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE Capsule-Shaped Tablet E White"
    ],
    "spl_unclassified_section": [
        "Drug Facts",
        "Packaged and distributed by Lil' Drug Store Products, Inc. with the permission of GSK Consumer Healthcare"
    ],
    "active_ingredient": [
        "Active ingredients (in each caplet) Purposes Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID nonsteroidal anti-inflammatory drug ) Pain reliever Caffeine 65 mg Pain reliever aid"
    ],
    "active_ingredient_table": [
        "<table width=\"60%\"><col width=\"70%\" align=\"left\" valign=\"top\"/><col width=\"30%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each caplet)</content></content></th><th><content styleCode=\"bold\"><content styleCode=\"italics\">Purposes</content></content></th></tr></thead><tbody><tr><td>Acetaminophen 250 mg</td><td>Pain reliever</td></tr><tr><td>Aspirin 250 mg (NSAID <footnote ID=\"foot1\">nonsteroidal anti-inflammatory drug</footnote>) </td><td>Pain reliever</td></tr><tr><td>Caffeine 65 mg</td><td>Pain reliever aid</td></tr></tbody></table>"
    ],
    "purpose": [
        "Active ingredients (in each caplet) Purposes Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID nonsteroidal anti-inflammatory drug ) Pain reliever Caffeine 65 mg Pain reliever aid"
    ],
    "purpose_table": [
        "<table width=\"60%\"><col width=\"70%\" align=\"left\" valign=\"top\"/><col width=\"30%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each caplet)</content></content></th><th><content styleCode=\"bold\"><content styleCode=\"italics\">Purposes</content></content></th></tr></thead><tbody><tr><td>Acetaminophen 250 mg</td><td>Pain reliever</td></tr><tr><td>Aspirin 250 mg (NSAID <footnote ID=\"foot1\">nonsteroidal anti-inflammatory drug</footnote>) </td><td>Pain reliever</td></tr><tr><td>Caffeine 65 mg</td><td>Pain reliever aid</td></tr></tbody></table>"
    ],
    "indications_and_usage": [
        "Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps"
    ],
    "warnings": [
        "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 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. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock 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 heart beat. Do not use if you have ever had an allergic reaction to acetaminophen, 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 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 you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition 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 ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms occur These could be signs of a serious condition 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."
    ],
    "do_not_use": [
        "Do not use if you have ever had an allergic reaction to acetaminophen, 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_doctor": [
        "Ask a doctor before use if you have liver disease 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 you have asthma"
    ],
    "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition"
    ],
    "stop_use": [
        "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 ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms occur These could be signs of a serious condition"
    ],
    "pregnancy_or_breast_feeding": [
        "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": [
        "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."
    ],
    "dosage_and_administration": [
        "Directions do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours under 12 years: ask a doctor"
    ],
    "storage_and_handling": [
        "Other information store at 20\u00b0-25\u00b0C (68\u00b0-77\u00b0F) read all product information before using. Keep this box for important information."
    ],
    "inactive_ingredient": [
        "Inactive ingredients benzoic acid, carnauba wax, FD&C blue #1, hypromellose, light mineral oil, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide"
    ],
    "questions": [
        "Questions or comments? 1-800-452-0051"
    ],
    "package_label_principal_display_panel": [
        "Excedrin Extra Strength - 6 Caplet Pouch Carton, Lil' Drug Store - PDP/Package EXCEDRIN \u00ae EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine Pain Reliever / Pain Reliever Aid 6 Caplets 3 PACKETS OF 2 CAPLETS Lil' Drug Store \u00ae PDP",
        "Excedrin Extra Strength 4ct, TRAVEL BASIX - PDP/Package EXCEDRIN EXTRA STRENGTH Acetaminophen , Aspirin (NSAID) and Caffiene Pain Reliever / Pain Reliever Aid [caplets image] 4 Caplets Total (2) 2ct Packets [TRAVEL BASIX logo] PDP/Package",
        "Excedrin Extra Strength, 4ct CVP HEALTH - PDP/Package EXCEDRIN EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffiene Pain Reliever / Pain Reliever Aid [caplets image] 4 Caplets Total (2) 2ct Packets [CVP HEALTH logo] PDP/Package",
        "Excedrin Extra Strength, 25pc Dispens-It Box EXCEDRIN EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine Pain Reliever / Pain Reliever Aid [caplets image] 25 PACKETS OF 2 CAPLETS EACH PDP/Package",
        "Excedrin Extra Strength, 30pc Dispens-It Box EXCEDRIN EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine Pain Reliever / Pain Reliever Aid [caplets image] 30 PACKETS OF 2 CAPLETS EACH PDP/Package"
    ],
    "set_id": "7f0f8b3c-c226-4a3a-af46-a708f345e4f5",
    "id": "458c59d3-e231-99ac-e063-6394a90ac131",
    "effective_time": "20251209",
    "version": "10",
    "openfda": {
        "application_number": [
            "M013"
        ],
        "brand_name": [
            "Excedrin Extra Strength, TRAVEL BASIX",
            "Excedrin Extra Strength, CVP HEALTH",
            "Excedrin Extra Strength"
        ],
        "generic_name": [
            "ACETAMINOPHEN, ASPIRIN, AND CAFFEINE"
        ],
        "manufacturer_name": [
            "Lil Drug Store Products, Inc"
        ],
        "product_ndc": [
            "66715-6410",
            "66715-9810",
            "66715-6510"
        ],
        "product_type": [
            "HUMAN OTC DRUG"
        ],
        "route": [
            "ORAL"
        ],
        "substance_name": [
            "ACETAMINOPHEN",
            "ASPIRIN",
            "CAFFEINE"
        ],
        "rxcui": [
            "209468",
            "308297"
        ],
        "spl_id": [
            "458c59d3-e231-99ac-e063-6394a90ac131"
        ],
        "spl_set_id": [
            "7f0f8b3c-c226-4a3a-af46-a708f345e4f5"
        ],
        "package_ndc": [
            "66715-9810-2",
            "66715-9810-3",
            "66715-9810-7",
            "66715-9810-8",
            "66715-6410-2",
            "66715-6510-2"
        ],
        "is_original_packager": [
            true
        ],
        "nui": [
            "N0000175739",
            "N0000175729",
            "N0000175790",
            "M0023046",
            "N0000000160",
            "N0000008836",
            "M0001335",
            "N0000175722",
            "N0000175578",
            "N0000008832"
        ],
        "pharm_class_epc": [
            "Central Nervous System Stimulant [EPC]",
            "Methylxanthine [EPC]",
            "Nonsteroidal Anti-inflammatory Drug [EPC]",
            "Platelet Aggregation Inhibitor [EPC]"
        ],
        "pharm_class_pe": [
            "Central Nervous System Stimulation [PE]",
            "Decreased Prostaglandin Production [PE]",
            "Decreased Platelet Aggregation [PE]"
        ],
        "pharm_class_cs": [
            "Xanthines [CS]",
            "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_moa": [
            "Cyclooxygenase Inhibitors [MoA]"
        ],
        "unii": [
            "362O9ITL9D",
            "3G6A5W338E",
            "R16CO5Y76E"
        ]
    }
}