Acetaminophen Extra Strength
Generic: ACETAMINOPHEN 500MG/15ML
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.
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"
]
}
}