"],"ask_doctor":["Ask a doctor before use if the child have ▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ glaucoma ▪ a breathing problem such as chronic bronchitis ▪ persistent or chronic cough such as occurs with asthma ▪ cough that occurs with too much phlegm (mucus)"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the child is ▪ taking the blood thinning drug warfarin ▪ taking sedatives or tranquilizers"],"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. ▪ To make child sleepy ▪ with any other drug containing diphenhydramine, even one used on the skin ▪ in a child who is 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."],"dosage_and_administration":["Directions ▪ this product does not contain directions or complete warnings for adult use ▪ do not give more than directed (see Overdose warning) ▪ measure only with dosing cup provided ▪ do not use dosing cup with other products ▪ dose as follows or as directed by a doctor ▪ children 6 years to 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in 24-hours period ▪ children under 6 years of age: do not use"],"effective_time":"20260819","id":"e1d05e87-3e21-4047-a40e-99af2d87282d","inactive_ingredient":["Inactive ingredients anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, natural and artificial flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum."],"indications_and_usage":["Uses ▪ temporarily relieves these common cold and flu symptoms: ▪ cough ▪ nasal congestion ▪ minor aches and pains ▪ sore throat ▪ headache ▪ runny nose ▪ sneezing ▪ temporarily reduces fever ▪ controls cough to help you get to sleep"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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."],"openfda":{"application_number":["M010"],"brand_name":["CVS Childrens Nighttime Multi Symptom Cold"],"generic_name":["ACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["CVS PHARMACY"],"package_ndc":["51316-733-04"],"product_ndc":["51316-733"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1375932"],"spl_id":["e1d05e87-3e21-4047-a40e-99af2d87282d"],"spl_set_id":["9b244ac8-4ca7-43a0-b328-88f15f0fcc9d"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40","04JA59TNSJ"]},"overdosage":["Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Compare to the active ingredients in Children’s Mucinex ® Night Time Multi-Symptom Cold NDC# 51316-733-04 Children’s Night Time Muti-Symptom Cold Acetaminophen Pain Reliever/Fever Reducer Diphenhydramine HCl Antihistamine/Cough Suppressant Phenylephrine HCl Nasal Decongestant Relieves Stuffy Nose Controls Cough Relieves Fever & Sore Throat Relieves Runny Nose & Sneezing Dosing Cup Included For Ages 6 & Over Very Berry Flavor Naturally and Artificially Flavored 4 FL OZ (118 mL) *This product is not manufactured or distributed by RB Health (US), distributor Children’s Mucinex ® Nighttime Multi-Symptoms Cold.. TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING. Distributed by: CVS Children's Nighttime Multi-Symptoms Cold 4fl oz 118 mL"],"purpose":["Active ingredients (in each 10 mL) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl 5 mg Nasal decongestant"],"purpose_table":["
Active ingredients (in each 10 mL)
Purposes
Acetaminophen 325 mg
Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg
Antihistamine/cough suppressant
Phenylephrine HCl 5 mg
Nasal decongestant
"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"9b244ac8-4ca7-43a0-b328-88f15f0fcc9d","spl_product_data_elements":["CVS Childrens Nighttime Multi Symptom Cold Acetaminophen , Diphenhydramine Hydrochloride,Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 POTASSIUM CITRATE PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if ▪ nervousness, dizziness, or sleeplessness occur ▪ pain, nasal congestion, or cough gets worse or lasts more than 5 days ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information ▪ each 10 mL contains: sodium 4 mg ▪ store at room temperature ▪ do not refrigerate"],"version":"6","warnings":["Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: ▪ more than 5 doses in 24 hours, which is the maximum daily amount ▪ with other drugs containing acetaminophen 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 ▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ▪ To make child sleepy ▪ with any other drug containing diphenhydramine, even one used on the skin ▪ in a child who is 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 the child have ▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ glaucoma ▪ a breathing problem such as chronic bronchitis ▪ persistent or chronic cough such as occurs with asthma ▪ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if the child is ▪ taking the blood thinning drug warfarin ▪ taking sedatives or tranquilizers When using this product ▪ do not use more than directed (see Overdose warning) ▪ excitability may occur, especially in children ▪ marked drowsiness may occur ▪ sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if ▪ nervousness, dizziness, or sleeplessness occur ▪ pain, nasal congestion, or cough gets worse or lasts more than 5 days ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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."],"when_using":["When using this product ▪ do not use more than directed (see Overdose warning) ▪ excitability may occur, especially in children ▪ marked drowsiness may occur ▪ sedatives and tranquilizers may increase drowsiness"]}