{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-09", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "FirstCare Childrens Pain Fever Acetaminophen Acetaminophen 80 mg HYDROXYPROPYL BETADEX GLYCERYL MONO AND DIPALMITOSTEARATE SUCRALOSE STEVIA LEAF SODIUM CHLORIDE CARRAGEENAN MALTODEXTRIN MONOBASIC POTASSIUM PHOSPHATE WATER SUCROSE CORN SYRUP D&C RED NO. 33 STARCH, CORN ACETAMINOPHEN ACETAMINOPHEN 7" ], "active_ingredient": [ "Active ingredient (in each chewable tablet) Acetaminophen 80 mg" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache temporarily reduces fever" ], "warnings": [ "Warnings Liver warning: thisproduct 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 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. if your child is allergic to acetaminophen or any 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 new symptoms occur redness or swelling is present These could be signs of a serious condition. Keep out of reach of children. Overdose warning: 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." ], "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 of the inactive ingredients in this product." ], "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." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning)." ], "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 new symptoms occur redness or swelling is present These could be signs of a serious condition." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "overdosage": [ "Overdose warning: 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." ], "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) Instruct child to chew each piece thoroughly before swallowing find right dose on chart below. If possible, use weight to dose; otherwise, use age repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lbs.) Age (yrs.) Dose (chewable tablet)* Under 24 Under 2 years Ask a doctor 24-35 2-3 years 2 chewable tablets 36-47 4-5 years 3 chewable tablets 48-59 6-8 years 4 chewable tablets 60-71 9-10 years 5 chewable tablets 72-95 11 years 6 chewable tablets * or as directed by a doctor" ], "dosage_and_administration_table": [ "
Weight (lbs.)Age (yrs.)Dose (chewable tablet)*
Under 24Under 2 yearsAsk a doctor
24-352-3 years2 chewable tablets
36-474-5 years3 chewable tablets
48-596-8 years4 chewable tablets
60-719-10 years5 chewable tablets
72-9511 years6 chewable tablets
" ], "spl_unclassified_section": [ "Other information each chewable tablet contains: calcium 5 mg, magnesium 5 mg, potassium 10 mg, sodium 5 mg. low sodium Store in a cool dry place between 20-25°C (68-77°F). Child Resistant Container; do not use if printed seal under cap is broken or missing.", "Patents: www.uspharmaltd.com/patent" ], "inactive_ingredient": [ "Inactive ingredients artificial flavors, corn syrup, D&C red no. 33, geleol mono and diglycerides, hydroxypropyl betadex, maltodextrin, monobasic potassium phosphate, pregelatinized starch, purified water, seaweed extract (carrageenan), sodium chloride, stevia sweetener, sucralose, sucrose." ], "questions": [ "Questions or comments? Call 1-800-227-6151" ], "package_label_principal_display_panel": [ "Principal Display Panel - Firstcare Children's Pain + Fever Acetaminophen 80 mg NDC 71594-702-13 FIRSTCARE CHILDREN'S Pain + Fever ACETAMINOPHEN 80 mg Pain Reliever Fever Reducer 24 Chewable Cherry Flavor Tablets Principal Display Panel-FirstCare Acetaminophen 80 mg" ], "set_id": "9fc05ba6-5667-457e-82c1-a8b4e16cadda", "id": "4db03017-4419-9205-e063-6394a90ac87b", "effective_time": "20260323", "version": "1", "openfda": { "application_number": [ "M013" ], "brand_name": [ "FirstCare Childrens Pain Fever Acetaminophen" ], "generic_name": [ "ACETAMINOPHEN 80 MG" ], "manufacturer_name": [ "USpharma Ltd" ], "product_ndc": [ "71594-702" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN" ], "rxcui": [ "307696" ], "spl_id": [ "4db03017-4419-9205-e063-6394a90ac87b" ], "spl_set_id": [ "9fc05ba6-5667-457e-82c1-a8b4e16cadda" ], "package_ndc": [ "71594-702-13" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D" ] } } ] }