{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-06-02",
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{
"spl_product_data_elements": [
"ACETAMINOPHEN PM Acetaminophen and Diphenhydramine Hydrochloride SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 28 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 ALUMINUM OXIDE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POVIDONE STARCH, PREGELATINIZED CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE dark blue and light blue ends G3"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredients (in each gelcap) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep-aid"
],
"active_ingredient_table": [
"
"
],
"indications_and_usage": [
"Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness"
],
"warnings": [
"Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this 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 with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients"
],
"ask_doctor": [
"Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma"
],
"ask_doctor_or_pharmacist": [
"Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers"
],
"when_using": [
"When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery"
],
"stop_use": [
"Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present 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."
],
"keep_out_of_reach_of_children": [
"Keep out of reach of children."
],
"dosage_and_administration": [
"Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours children under 12 years do not use"
],
"dosage_and_administration_table": [
"
adults and children 12 years and over
take 2 gelcaps at bedtimedo not take more than 2 gelcaps of this product in 24 hours
children under 12 years
do not use
"
],
"storage_and_handling": [
"Other information store between 20-25ºC (68-77ºF) retain carton for complete product information"
],
"inactive_ingredient": [
"Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, edible ink, FD&C blue #1, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL CAREone® NDC 72476-171-03 Compare to the actrive ingredients in Tylenol® PM Extra Strength† Extra Strength ACETAMINOPHEN PM Acetaminophen - Pain Reliever Diphenhydramine HCl - Nighttime Sleep Aid For Adults Actual Size 80 GELCAPS image description"
],
"set_id": "093199be-e92a-6f60-e063-6294a90a8533",
"id": "1adb0e1c-a806-ed20-e063-6294a90a46ee",
"effective_time": "20240614",
"version": "2",
"openfda": {
"application_number": [
"M013"
],
"brand_name": [
"ACETAMINOPHEN PM"
],
"generic_name": [
"ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE"
],
"manufacturer_name": [
"RETAIL BUSINESS SERVICES , LLC."
],
"product_ndc": [
"72476-171"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"ACETAMINOPHEN",
"DIPHENHYDRAMINE HYDROCHLORIDE"
],
"rxcui": [
"1092189"
],
"spl_id": [
"1adb0e1c-a806-ed20-e063-6294a90a46ee"
],
"spl_set_id": [
"093199be-e92a-6f60-e063-6294a90a8533"
],
"package_ndc": [
"72476-171-01",
"72476-171-03"
],
"is_original_packager": [
true
],
"upc": [
"0341520319624"
],
"unii": [
"362O9ITL9D",
"TC2D6JAD40"
]
}
}
]
}