{ "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", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "spl_product_data_elements": [ "daytime severe cold and cough and nighttime severe cold and cough Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl daytime severe cold and cough ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 ANHYDROUS CITRIC ACID MALTODEXTRIN POTASSIUM CHLORIDE FD&C RED NO. 40 SILICON DIOXIDE SUCRALOSE SUCROSE nighttime severe cold and cough ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID MALTODEXTRIN POTASSIUM CHLORIDE SILICON DIOXIDE SUCRALOSE SUCROSE FD&C YELLOW NO. 6" ], "active_ingredient": [ "Active ingredients (in each packet) – Daytime Severe Cold and Cough Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg", "Active ingredients (in each packet) - Nighttime Severe Cold and Cough Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg" ], "purpose": [ "Purposes - Daytime Severe Cold and Cough Pain reliever/fever reducer Cough Suppressant Nasal Decongestant", "Purpose - Nighttime Severe Cold and Cough Pain reliever/fever reducer Antihistamine/cough Suppressant Nasal Decongestant" ], "indications_and_usage": [ "Uses - Daytime Severe Cold and Cough • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • cough due to minor throat and bronchial irritation • temporarily reduces fever", "Uses - Nighttime Severe Cold and Cough • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • 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 Severe Cold and Cough and Nighttime Severe Cold and Cough 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 Is 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": [ "Do not use - Daytime Severe Cold and Cough • 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 a 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 - Nighttime Severe Cold and Cough • 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 a pharmacist. • with any other product containing diphenhydramine, even one used on 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "ask_doctor": [ "Ask a doctor before use if you have - Daytime Severe Cold and Cough • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • 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 before use if you have - Nighttime Severe Cold and Cough • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • 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 - Daytime Severe Cold and Cough taking the blood thinning drug warfarin", "Ask a doctor or pharmacist before use if you are - Nighttime Severe Cold and Cough • taking sedatives or tranquilizers • taking the blood thinning drug warfarin" ], "when_using": [ "When using this product - Daytime Severe Cold and Cough do not exceed recommended dosage", "When using this product - Nighttime Severe Cold and Cough • do not exceed recommended dosage • 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": [ "Stop use and ask a doctor if – Daytime Severe Cold and Cough /Nighttime Severe Cold and Cough • nervousness, dizziness, or sleeplessness occurs • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain, cough or nasal congestion 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." ], "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 (1-800-222-1222). 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 Severe Cold and Cough • do not use more than directed • take every 4 hours, while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose Adults and children 12 years of age and over One packet Children under 12 years of age Do not use • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat Directions Nighttime Severe Cold and Cough • do not use more than directed • take every 4 hours, while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctor. Age Dose Adults and children 12 years of age and over One packet Children under 12 years of age Do not use • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat", "Directions Nighttime Severe Cold and Cough • do not use more than directed • take every 4 hours, while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctor. Age Dose Adults and children 12 years of age and over One packet Children under 12 years of age Do not use • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat" ], "dosage_and_administration_table": [ "
Age Dose
Adults and children 12 years of age and over One packet
Children under 12 years of age Do not use
", "
Age Dose
Adults and children 12 years of age and over One packet
Children under 12 years of age Do not use
", "
Age Dose
Adults and children 12 years of age and over One packet
Children under 12 years of age Do not use
" ], "storage_and_handling": [ "Other information - Daytime Severe Cold and Cough • each packet contains: potassium 6 mg • store at room temperature. Protect from excessive heat and moisture", "Other information - Nighttime Severe Cold and Cough • each packet contains: potassium 6 mg • store at room temperature. Protect from excessive heat and moisture" ], "inactive_ingredient": [ "Inactive ingredients - Daytime Severe Cold and Cough citric acid ,FD&C blue#1, FD&C red 40#, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose", "Inactive ingredients - Nighttime Severe Cold and Cough citric acid, FD & C yellow #6, flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose," ], "questions": [ "Questions or comments? 1-866-467-2748" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Compare to active ingredients in Theraflu® Daytime Severe Cold and Cough and Nighttime Severe Cold & Cough* Value pack daytime severe cold and cough acetaminophen(pain reliever/ fever reducer) dextromethorphan HBr ( cough suppressant) phenylephrine HCl ( nasal decongestant) aspartame free, sodium free relief of nasal and sinus congestion,, cough ,body ache, sore throat pain, headache ,fever berry flavor infused with menthol and green tea flavors 6 PACKETS nighttime severe cold and cough acetaminophen –(pain reliever/ fever reducer) diphenhydramine HCl – (antihistamine/ cough suppressant) phenylephrine HCl – (nasal decongestant) aspartame free, sodium free relief of nasal congestion,, cough ,runny nose, sneezing, body ache, sore throat pain, headache ,fever honey lemon flavor infused with chamomile & white tea flavors 6 PACKETS READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE .KEEP CARTON FOR REFERENCE, DO NOT DISCARD. DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR 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 DAYTIME PRODUCT UNLESS DIRECTED BY DOCTOR. *These Products are not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Daytime Severe Cold & Cough and Theraflu Nighttime severe Cold & Cough Distributed by: Target Corporation. Minneapolis, MN 55403 TM &©2017 Target Brands, Inc. Tamper Evident Inner Unit Do not use if sealed packet is Torn or Broken up & up daytime severe cold and cough and nighttime severe cold and cough value pack" ], "package_label_principal_display_panel_table": [ "
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE .KEEP CARTON FOR REFERENCE, DO NOT DISCARD.
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR 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 DAYTIME PRODUCT UNLESS DIRECTED BY DOCTOR.
", "
Tamper Evident Inner Unit Do not use if sealed packet is Torn or Broken
" ], "set_id": "62eec235-431f-4429-b173-d4a9b45a4e36", "id": "62eec235-431f-4429-b173-d4a9b45a4e36", "effective_time": "20180118", "version": "1", "openfda": { "application_number": [ "part341" ], "brand_name": [ "daytime severe cold and cough and nighttime severe cold and cough" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL" ], "manufacturer_name": [ "Target Corporation" ], "product_ndc": [ "11673-542" ], "product_type": [ "HUMAN OTC DRUG" ], "rxcui": [ "1428880", "1659960", "1659967" ], "spl_id": [ "62eec235-431f-4429-b173-d4a9b45a4e36" ], "spl_set_id": [ "62eec235-431f-4429-b173-d4a9b45a4e36" ], "package_ndc": [ "11673-542-12", "11673-540-06", "11673-541-06" ], "is_original_packager": [ true ] } } ] }