View Drug - Acetaminophen Extra Strength
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Acetaminophen Extra Strength

Generic: ACETAMINOPHEN 500MG/15ML

100%
Basic Information
Manufacturer
Aldama Pharmaceuticals, Inc
Product Type
HUMAN OTC DRUG
Route of Administration
ORAL
FDA Set ID
48dc8d92-16ee-b359-e063-6294a90a26af
Purpose
Purpose Pain reliever/fever reducer
Indications & Usage
Uses Temporarily relieves minor aches and pains temporarily reduces fever
Warnings
Warnings Liver warning This product contains acetaminophen.

The maximum daily dose of this product is 6 tablespoonfuls in 24 hours.

Severe liver damage may occur if:you take more than 8 tablespoonfuls (4,000mg of acetaminophen) in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using the 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.
Technical Data
{
    "spl_product_data_elements": [
        "Acetaminophen Extra Strength Acetaminophen 500mg/15mL WATER SUCRALOSE ANHYDROUS CITRIC ACID POLYETHYLENE GLYCOL 350 PROPYLENE GLYCOL METHYLPARABEN PROPYLPARABEN SODIUM CITRATE ACETAMINOPHEN ACETAMINOPHEN"
    ],
    "active_ingredient": [
        "Active ingredient (in each 15 mL-teaspoonful) Acetaminophen 500 mg"
    ],
    "purpose": [
        "Purpose Pain reliever/fever reducer"
    ],
    "indications_and_usage": [
        "Uses Temporarily relieves minor aches and pains temporarily reduces fever"
    ],
    "warnings": [
        "Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Severe liver damage may occur if:you take more than 8 tablespoonfuls (4,000mg of acetaminophen) in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using the 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": [
        "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. if you are allergic to acetaminophen or any of the inactive ingredients in this product."
    ],
    "ask_doctor": [
        "Ask a doctor before use if your child has liver disease"
    ],
    "ask_doctor_or_pharmacist": [
        "Ask a doctor before use if you have taking the blood thinning drug warfarin."
    ],
    "when_using": [
        "When using this product do not exceed recommended dose"
    ],
    "stop_use": [
        "Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition."
    ],
    "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of overdose, get medical help or conbtact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms"
    ],
    "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding ask a health professional before use"
    ],
    "dosage_and_administration": [
        "Directions do not take more than directed Age DOSE Adults and children 12 years of age and older Take 1 to 2 tablespoonfuls every 4 to 6 hours as needed, not more than 6 Tablespoonfuls in 24 hours Children under 12 years Do not use"
    ],
    "dosage_and_administration_table": [
        "<table border=\"2\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\">Age</content></td><td><content styleCode=\"bold\">DOSE</content></td></tr><tr><td>Adults and children 12 years of age and older</td><td>Take 1 to 2 tablespoonfuls every 4 to 6 hours as needed, not more than 6 Tablespoonfuls in 24 hours</td></tr><tr><td>Children under 12 years</td><td>Do not use</td></tr></tbody></table>"
    ],
    "other_safety_information": [
        "Other information store at room temperature between 15-30\u00b0C (59-86\u00b0F) protect from freezing protect from light TAMPER EVIDENT do not use if foil seal over bottle opening is torn, broken or missing"
    ],
    "inactive_ingredient": [
        "Inactive Ingredient artificial and natural cherry flavor, citric acid, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose"
    ],
    "questions": [
        "Question or Comments? call 305-592-9216 or info@aldamapharm.com"
    ],
    "package_label_principal_display_panel": [
        "label"
    ],
    "set_id": "48dc8d92-16ee-b359-e063-6294a90a26af",
    "id": "51dbaacf-501a-5b1a-e063-6394a90a4824",
    "effective_time": "20260515",
    "version": "2",
    "openfda": {
        "application_number": [
            "M013"
        ],
        "brand_name": [
            "Acetaminophen Extra Strength"
        ],
        "generic_name": [
            "ACETAMINOPHEN 500MG/15ML"
        ],
        "manufacturer_name": [
            "Aldama Pharmaceuticals, Inc"
        ],
        "product_ndc": [
            "73564-817"
        ],
        "product_type": [
            "HUMAN OTC DRUG"
        ],
        "route": [
            "ORAL"
        ],
        "substance_name": [
            "ACETAMINOPHEN"
        ],
        "rxcui": [
            "307684"
        ],
        "spl_id": [
            "51dbaacf-501a-5b1a-e063-6394a90a4824"
        ],
        "spl_set_id": [
            "48dc8d92-16ee-b359-e063-6294a90a26af"
        ],
        "package_ndc": [
            "73564-817-08"
        ],
        "is_original_packager": [
            true
        ],
        "unii": [
            "362O9ITL9D"
        ]
    }
}