{ "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": 2 } }, "results": [ { "spl_product_data_elements": [ "ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCI EDETATE DISODIUM GLYCERIN PROPYLENE GLYCOL SORBITOL SOLUTION MENTHOL, UNSPECIFIED FORM ANHYDROUS CITRIC ACID SODIUM SACCHARIN SODIUM BENZOATE XANTHAN GUM FD&C RED NO. 40 WATER SODIUM CITRATE SUCRALOSE STEVIA LEAF PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN DOXYLAMINE SUCCINATE DOXYLAMINE FD&C BLUE NO. 2 Clear" ], "active_ingredient": [ "OneSsip Night Time Adult Severe Cold & Flu 15 mL Sachet Drug Facts Active ingredients (in each 15 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine Succinate 12.5 mg Phenylephrine HCl 10 mg" ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product taken with other drugs containing acetaminophen adult has 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": [ "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 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 heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema a sodium-restricted diet" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. taking sedatives or tranquilizer" ], "when_using": [ "When using this product, do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness" ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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. Quick 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 mL = milliliter take only as directed do not exceed 4 doses (4 Sachets) per 24 hours follow the instruction given on this carton for your easy use Age (Years) Dose (mL) adults & children 12 yrs & over 15 mL (1 Sachet) every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use" ], "dosage_and_administration_table": [ "
Age (Years)Dose (mL)
adults & children 12 yrs & over15 mL (1 Sachet) every 4 hours
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
" ], "other_safety_information": [ "Other information store between 20-25°C (68-77°F) do not use if carton or sachet is torn, broken or punctured." ], "inactive_ingredient": [ "Inactive ingredients citric acid anhydrous, FD&C Red No. 40, FD&C Blue No. 2, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum, stevia powder, menthol, sodium edetate." ], "questions": [ "Question or comments? call 1-516-675-8915" ], "recent_major_changes": [ "change" ], "package_label_principal_display_panel": [ "NDC 87078-872-32" ], "set_id": "4970b8bc-3c7b-4b8a-e063-6294a90a7f1b", "id": "4970b8dd-9342-59a3-e063-6294a90a3a8d", "effective_time": "20260128", "version": "1", "openfda": { "application_number": [ "M012" ], "brand_name": [ "ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI" ], "manufacturer_name": [ "MEDWISE LIFESCIENCES INC." ], "product_ndc": [ "87078-872" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE", "DOXYLAMINE SUCCINATE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "2733907" ], "spl_id": [ "4970b8dd-9342-59a3-e063-6294a90a3a8d" ], "spl_set_id": [ "4970b8bc-3c7b-4b8a-e063-6294a90a7f1b" ], "package_ndc": [ "87078-872-03", "87078-872-32" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ" ] } } ] }