{"active_ingredient":["ACTIVE INGREDIENTS (in each 10 mL) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenyephrine HCl 5 mg"],"ask_doctor":["ASK A DOCTOR BEFORE USE IF THE CHILD HAS liver disease thyroid disease diabetes heart disease high blood pressure 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 YOUR 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 a child sleepy with any other product 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving 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) shake well before use do not give more than 5 doses in any 24-hour period if needed, repeat dose every 4 hours while symptoms last do not give more than 5 days unless directed by a doctor measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter Children 6 to under 12 years of age: 10 mL in dosing cup provided. Children under 6 years of age: do not use."],"effective_time":"20241220","id":"b98874b7-3ef3-4414-b475-0ed764b22aed","inactive_ingredient":["INACTIVE INGREDIENTS citric acid anhydrous, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum."],"indications_and_usage":["USE(S) temporarily relieves these common cold and flu symptoms: cough sore throat nasal congestion runny nose minor aches and pains headache sinus congestion and pressure sneezing temporarily reduces fever controls cough to help your child 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. Quick medical attention is critical even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Equate Childrens Multi symptom Cold Nighttime"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Wal-Mart Stores, Inc."],"package_ndc":["49035-623-03"],"product_ndc":["49035-623"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1375932"],"spl_id":["b98874b7-3ef3-4414-b475-0ed764b22aed"],"spl_set_id":["bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40","04JA59TNSJ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 49035-623-03 equate Compare to Children's Mucinex® Nighttime Multi-Symptom Cold active ingredients* Children's MULTI-SYMPTOMS COLD NIGHTTIME Acetaminophen 325 mg Pain reliever/Fever Reducer Diphenhydramine HCl 12.5 mg Antihistamine/Cough Suppressant Phenylephrine HCl 5 mg Nasal Decongestant AGES 6 to 12 YEARS Relieves headache and fever Soothes cough Relieves nasal congestion Relieves runny nose and sneezing Mixed Berry Flavored 4 FL OZ (118 mL) 623-Equate-4oz"],"purpose":["PURPOSE Pain reliever / fever reducer Antihistamine/Cough Suppressant Nasal decongestant"],"set_id":"bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee","spl_product_data_elements":["Equate Childrens Multi symptom Cold Nighttime Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE XANTHAN GUM Mixed Berry"],"spl_unclassified_section":["QUESTIONS OR COMMENTS 1-888-287-1915"],"stop_use":["STOP USE AND ASK 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 rash or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["OTHER INFORMATION each 10 mL contains: sodium 10 mg store between 15-30°C (59-86°F) do not refrigerate dosing cup provided"],"version":"4","warnings":["WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hous, 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."],"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 dowsiness"]}