{"active_ingredient":["Active ingredient & Purpose Active ingredient (in each 5 mL) Purpose Acetaminophen 160 mg Pain reliever/ fever reducer"],"active_ingredient_table":["
Active ingredient (in each 5 mL)Purpose
Acetaminophen 160 mgPain reliever/ fever reducer
"],"ask_doctor":["Ask a doctor before use if your child has liver disease."],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin."],"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 your child is allergic to acetaminophen or any other of the inactive ingredients in this product"],"dosage_and_administration":["Directions this product does not contain directions or complete warnings for adult use shake well before using use only enclosed dosing cup. Do not use any other dosing device mL = milliliter use the dose that corresponds to your child's age Age (years) Dose (mL)* under 2 consult a doctor 2 to under 4 5 mL 4 to under 5 7.5 mL 6 to under 8 10 mL 9 to under 10 12.5 mL 11 to under 12 15 mL *Dose may be repeated every 4 hours while symptoms persist, up to five times a day or as directed by a doctor."],"dosage_and_administration_table":["
Age (years)Dose (mL)*
under 2consult a doctor
2 to under 45 mL
4 to under 57.5 mL
6 to under 8 10 mL
9 to under 1012.5 mL
11 to under 1215 mL
"],"effective_time":"20240304","id":"12dcac76-11bc-2c3b-e063-6394a90a35c6","inactive_ingredient":["Inactive ingredients anhydrous citric acid, butylparaben, FD&C red # 40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum"],"indications_and_usage":["Uses For the temporary relief of minor aches and pain due to: a cold headache sore throat toothache and to reduce fever"],"keep_out_of_reach_of_children":["Keep out of reach of children. Keep out of reach of children."],"openfda":{"application_number":["M013"],"brand_name":["Dolex Children Pain and Fever"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"package_ndc":["55758-026-04"],"product_ndc":["55758-026"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["307668"],"spl_id":["12dcac76-11bc-2c3b-e063-6394a90a35c6"],"spl_set_id":["f9158463-aeb1-5de0-e053-6294a90a748b"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"other_safety_information":["Other information each 5 mL contains: sodium 3 mg store between 68-77° F (20-25° C) do not refrigerate keep carton for full directions for use"],"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 at 1-800-222-1222. Prompt 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 PDP DCPF"],"purpose":["Active ingredient (in each 5 mL) Purpose Acetaminophen 160 mg Pain reliever/ fever reducer"],"purpose_table":["
Active ingredient (in each 5 mL)Purpose
Acetaminophen 160 mgPain reliever/ fever reducer
"],"questions":["Questions? +1-866-359-3478 (9 AM - 5 PM EST) or pharmadel.com ** This product is not manufactured or distributed by Mcneil Consumer Healthcare, distributor of Children’s Tylenol® Oral Suspension."],"set_id":"f9158463-aeb1-5de0-e053-6294a90a748b","spl_product_data_elements":["Dolex Children Pain and Fever ACETAMINOPHEN XANTHAN GUM CELLULOSE, MICROCRYSTALLINE GLYCERIN BUTYLPARABEN ANHYDROUS CITRIC ACID FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM"],"spl_unclassified_section":["Drug Facts","Distributed by: PHARMADEL LLC. New Castle, DE 19720"],"stop_use":["Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days any new symptoms occur redness or swelling is present"],"version":"3","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. If your child is allergic to acetaminophen or any other of the inactive ingredients in this product Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning). Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days any new symptoms occur redness or swelling is present 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 at 1-800-222-1222. 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 exceed recommended dose (see overdose warning)."]}