{"active_ingredient":["Active ingredients (in each 5 mL) Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg"],"ask_doctor":["Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma a breathing problem such as chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the child is taking sedative or tranquilizers."],"do_not_use":["Do not use in a child under 4 years of age 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. with any other product containing diphenhydramine, even one used on skin for the purpose of making your child sleepy"],"dosage_and_administration":["Directions Do not give more than 6 doses in 24 hours unless directed by a doctor. measure only with dosing cup provided Do not use any other dosing device keep dosing cup with product mL=mililiter shake well before using Age Dose children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years do not use unless directed by a doctor children under 4 years of age do not use"],"dosage_and_administration_table":["
AgeDose
children 6 to under 12 years 10 mL every 4 hours
children 4 to under 6 yearsdo not use unless directed by a doctor
children under 4 years of age do not use
"],"effective_time":"20240515","id":"699a52c6-053a-43f9-b7fc-d719aead253d","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate"],"indications_and_usage":["Uses temporarily relieves sneezing runny nose itchy nose or throat itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritations as may occur with a cold"],"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 (1-800-222-1222) right away."],"openfda":{"application_number":["M012"],"brand_name":["Childrens Cold and Cough Nighttime"],"generic_name":["DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Safeway, Inc."],"package_ndc":["21130-379-04"],"product_ndc":["21130-379"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1236048"],"spl_id":["699a52c6-053a-43f9-b7fc-d719aead253d"],"spl_set_id":["cbbec807-f882-4c6a-b1cd-c7fd5ce70cad"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["TC2D6JAD40","04JA59TNSJ"],"upc":["0321130788843"]},"package_label_principal_display_panel":["Principal Display Panel Compare to Children's Triaminic® NightTime Cold & Cough active ingredients* Childrens's Nighttime Cold & Cough Relief FOR AGES 6-11 YEARS Diphenhydramine HCl 6.25 mg - Antihistamine/Cough Suppressant Phenylephrine HCl 2.5 mg - Nasal Decongestant GRAPE FLAVOR Relief of: Cough, runny, stuffy nose itchy throat Alcohol-Free FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Night Time Cold & Cough. DISTRIBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 www.betterlivingbrandsLLC.com","Package Label SIGNATURE CARE Children's Nighttime Cold and Cough Relief Grape Flavor Diphenhydramine HCL 6.25 mg, Phenylephrine HCL 2.5 mg"],"purpose":["Purposes Antihistamine/Cough suppressant Nasal decongestant"],"questions":["Questions or comments? Call 1-888-723-3929 Monday-Friday 7AM-6PM PST"],"set_id":"cbbec807-f882-4c6a-b1cd-c7fd5ce70cad","spl_product_data_elements":["Childrens Cold and Cough Nighttime Diphenhydramine HCl, Phenylephrine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM SODIUM BENZOATE ANHYDROUS CITRIC ACID EDETATE DISODIUM MALTITOL PROPYLENE GLYCOL WATER FD&C RED NO. 40 TRISODIUM CITRATE DIHYDRATE FD&C BLUE NO. 1"],"spl_unclassified_section":["Other Information each 5 mL contains: sodium 3 mg store between 20-25ºC (68-77ºF). Do not refrigerate. protect from light"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with fever, rash or persistent headache. These could be signs of a serious condition."],"version":"7","warnings":["Warnings Do not use in a child under 4 years of age 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. with any other product containing diphenhydramine, even one used on skin for the purpose of making your child sleepy Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma a breathing problem such as chronic bronchitis Ask a doctor or pharmacist before use if the child is taking sedative or tranquilizers. When using this product, do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with fever, rash or persistent headache. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"when_using":["When using this product, do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children sedatives and tranquilizers may increase drowsiness"]}