{"active_ingredient":["Active ingredients (in each 20 mL) Acetaminophen 650 mg Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have • liver disease • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, emphysema or chronic bronchitis • if you have glaucoma or difficulty in urination due to enlargement of prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin • taking any other pain reliever/fever reducer"],"do_not_use":["Do not use • to sedate a child or to make a child sleepy • 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"],"dosage_and_administration":["Directions • do not take more than 6 doses in any 24-hour period • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age Age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use"],"dosage_and_administration_table":["
Agedose
adults and children 12 years and over20 mL every 4 hours
children under 12 yearsdo not use
"],"effective_time":"20240426","id":"e1aff09c-8c75-45af-b83c-71be0cb7309b","inactive_ingredient":["Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural & artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum"],"indications_and_usage":["Uses • temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies: • cough due to minor throat and bronchial irritation • minor aches and pains • sore throat pain • headache • runny nose, sneezing, itchy watery eyes • itching of the nose and throat • temporarily relieves your cough to help you sleep • temporarily reduces fever"],"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."],"openfda":{"application_number":["M012"],"brand_name":["Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime"],"generic_name":["ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0031-8770-12","0031-8770-18"],"product_ndc":["0031-8770"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2374554"],"spl_id":["e1aff09c-8c75-45af-b83c-71be0cb7309b"],"spl_set_id":["7decc168-e847-4bbe-910b-26081469406f"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL ADULT Robitussin Honey Nighttime SEVERE Cough, Flu + Sore Throat ACETAMINOPHEN (Pain Reliever/Fever Reducer) DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant) MAXIMUM STRENGTH ✓ Controls Cough ✓ Relieves Runny Nose & Sneezing ✓ Relieves Fever & Body Aches Taste the Real Honey with Vanilla CF NIGHTTIME MAX For Ages 12+ 8 FL OZ (237 mL) Robitussin Honey SC F+ST NT 8 oz"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/Fever reducer Antihistamine/Cough suppressant"],"questions":["Questions or comments? call weekdays from 8 AM to 6 PM EST at 1-800-245-1040"],"set_id":"7decc168-e847-4bbe-910b-26081469406f","spl_product_data_elements":["Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime acetaminophen and diphenhydramine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED GLYCERIN HONEY POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SODIUM GLUCONATE SUCRALOSE XANTHAN GUM"],"spl_unclassified_section":["Drug Facts","Additional information Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. Distributed by: Haleon, Warren, NJ 07059 For most recent product information, visit www.robitussin.com Trademarks owned or licensed by Haleon. ©2023 Haleon or licensor. Pat. Info www.productpats.com Made in Canada"],"stop_use":["Stop use and ask a doctor if • pain or cough gets worse or lasts more than 7 days • 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."],"storage_and_handling":["Other information • each 20 mL contains : sodium 22 mg • store at 20-25°C (68-77°F). Do not refrigerate."],"version":"7","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 doses in any 24-hour period, which is the maximum daily amount • 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 • to sedate a child or to make a child sleepy • 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 Ask a doctor before use if you have • liver disease • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, emphysema or chronic bronchitis • if you have glaucoma or difficulty in urination due to enlargement of prostate gland Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin • taking any other pain reliever/fever reducer When using this product • do not use more than directed • marked drowsiness may occur • avoid alcoholic drinks • 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 • pain or cough gets worse or lasts more than 7 days • 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. 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."],"when_using":["When using this product • do not use more than directed • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children"]}