{
"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": "2026-06-10",
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{
"spl_product_data_elements": [
"Theraflu Severe Cold Relief Acetaminophen, Dextromethorphan HBr, Diphenphydramine HCl, Guaifenesin Theraflu Severe Cold Relief Chest Congestion Daytime Acetaminophen, Dextromethorphan HBr, Guaifenesin ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM Theraflu Severe Cold Relief Nighttime Acetaminophen, Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM"
],
"active_ingredient": [
"Active ingredients (in each 30 mL) (Daytime) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg",
"Active ingredients (in each 30 mL) (Nighttime) Acetaminophen 650 mg Diphenhydramine HCl 25 mg"
],
"purpose": [
"Purposes (Daytime) Pain reliever/Fever reducer Cough suppressant Expectorant",
"Purposes (Nighttime) Pain reliever/Fever reducer Antihistamine/Cough suppressant"
],
"indications_and_usage": [
"Uses (Daytime) • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • cough due to minor throat and bronchial irritation • temporarily reduces fever • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive",
"Uses (Nighttime) • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • runny nose • sneezing • itchy nose or throat • itchy, watery eyes due to hay fever • cough due to minor throat and bronchial irritation • temporarily reduces fever"
],
"warnings": [
"Warnings (Daytime) 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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. Do not use • in a child under 12 years of age • if you are allergic to acetaminophen • 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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • liver disease • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin Stop use and ask a doctor if • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain or cough gets worse or lasts more than 7 days • cough comes back or occurs with rash or headache that lasts 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.",
"Warnings (Nighttime) 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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. Do not use • in a child under 12 years of age • if you are allergic to acetaminophen • 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 the skin • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • liver disease • glaucoma • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • avoid alcoholic drinks • marked drowsiness may occur • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children Stop use and ask a doctor if • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain or cough gets worse or lasts more than 7 days • cough comes back or occurs with rash or headache that lasts 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 • in a child under 12 years of age • if you are allergic to acetaminophen • 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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.",
"Do not use • in a child under 12 years of age • if you are allergic to acetaminophen • 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 the skin • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."
],
"ask_doctor": [
"Ask a doctor before use if you have • liver disease • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema",
"Ask a doctor before use if you have • liver disease • glaucoma • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema"
],
"ask_doctor_or_pharmacist": [
"Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin",
"Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin"
],
"stop_use": [
"Stop use and ask a doctor if • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain or cough gets worse or lasts more than 7 days • cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.",
"Stop use and ask a doctor if • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain or cough gets worse or lasts more than 7 days • cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition."
],
"pregnancy_or_breast_feeding": [
"If pregnant or breast-feeding, ask a health professional before use.",
"If pregnant or breast-feeding, ask a health professional before use."
],
"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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.",
"Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 (Daytime) • do not use more than directed • measure the dose correctly using the enclosed dosing cup • take every 4 hours in dosing cup provided, while symptoms persist • do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age do not use",
"Directions (Nighttime) • do not use more than directed • measure the dose correctly using the enclosed dosing cup • take every 4 hours in dosing cup provided, while symptoms persist • do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age do not use"
],
"dosage_and_administration_table": [
"
Age
Dose
adults and children 12 years of age and over
30 mL
children under 12 years of age
do not use
",
"
Age
Dose
adults and children 12 years of age and over
30 mL
children under 12 years of age
do not use
"
],
"spl_unclassified_section": [
"Other information (Daytime) • each 30 mL contains: potassium 30 mg, sodium 13 mg • store at controlled room temperature 20°-25°C (68°-77°F)",
"Other information (Nighttime) • each 30 mL contains: potassium 30 mg, sodium 13 mg • store at controlled room temperature 20°-25°C (68°-77°F)",
"Additional Information DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD. DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR. DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING. *Temporarily controls cough to help you rest. This is not a sleep aid."
],
"inactive_ingredient": [
"Inactive ingredients (Daytime) acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate",
"Inactive ingredients (Nighttime) acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate"
],
"questions": [
"Questions or comments? (Daytime) 1-855-328-5259",
"Questions or comments? (Nighttime) 1-855-328-5259"
],
"when_using": [
"When using this product • avoid alcoholic drinks • marked drowsiness may occur • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children"
],
"package_label_principal_display_panel": [
"Principal Display Panel (Day/Night Combination) MULTI-SYMPTOM COLD RELIEF NEW FORMULA VALUE PACK DAYTIME FORMULA SEVERE COLD RELIEF MULTI-SYMPTOM COLD RELIEF NEW FORMULA THERAFLU SEVERE COLD RELIEF + CHEST CONGESTION ACETAMINOPHEN Pain Reliever/Fever Reducer Dextromethorphan HBr Cough suppressant Guaifenesin / Expectorant DAYTIME FORMULA Powerful formula that relieves: / Chest congestion / Thins and loosens mucus / Head and body ache / Fever / Cough / Sore throat pain 8.3 FL OZ (245.5 mL) Berry Flavor SEVERE COLD RELIEF HELPS YOU REST* MULTI-SYMPTOM COLD RELIEF NEW FORMULA THERAFLU SEVERE COLD RELIEF NIGHTTIME Acetaminophen Pain Reliever/Fever Reducer Diphenhydramine HCl Antihistamine/Cough Suppressant HELPS YOU REST* Powerful formula that relieves: / Cough / Sore throat pain / Head and body ache / Fever / Runny nose / Sneezing 8.3 FL OZ (245.5 mL) Berry Flavor 2-8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL) USE ONLY AS DIRECTED Theraflu-SCR-DayNight-ComboPack"
],
"set_id": "b01cc9f5-53f2-40d8-acf1-6de180b3d0bf",
"id": "b01cc9f5-53f2-40d8-acf1-6de180b3d0bf",
"effective_time": "20241014",
"version": "1",
"openfda": {
"application_number": [
"M012"
],
"brand_name": [
"Theraflu Severe Cold Relief"
],
"generic_name": [
"ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN"
],
"manufacturer_name": [
"Haleon US Holdings LLC"
],
"product_ndc": [
"0067-0107"
],
"product_type": [
"HUMAN OTC DRUG"
],
"rxcui": [
"1042695",
"1294607",
"2695452"
],
"spl_id": [
"b01cc9f5-53f2-40d8-acf1-6de180b3d0bf"
],
"spl_set_id": [
"b01cc9f5-53f2-40d8-acf1-6de180b3d0bf"
],
"package_ndc": [
"0067-0107-01",
"0067-0104-08",
"0067-0105-08"
],
"is_original_packager": [
true
]
}
}
]
}