{ "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": "2026-10-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "UP AND UP CHILDRENS ACETAMINOPHEN Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID CALCIUM SULFATE, UNSPECIFIED FORM CARRAGEENAN GLYCERIN HYDROXYETHYL CELLULOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION SUCRALOSE SODIUM PHOSPHATE, TRIBASIC opaque,viscous" ], "active_ingredient": [ "Active ingredient (in each 5 mL) Acetaminophen 160 mg" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "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 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 has ever had an allergic reaction to this product or any of its ingredients 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 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 has ever had an allergic reaction to this product or any of its ingredients" ], "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. 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 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) • shake well before using • mL = milliliter • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL 36-47 4-5 years 7.5 mL 48-59 6-8 years 10 mL 60-71 9-10 years 12.5 mL 72-95 11 years 15 mL *or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device." ], "dosage_and_administration_table": [ "
Weight (lb)Age (yr)Dose (mL)*
under 24under 2 yearsask a doctor
24-352-3 years5 mL
36-474-5 years7.5 mL
48-596-8 years10 mL
60-719-10 years12.5 mL
72-9511 years15 mL
" ], "storage_and_handling": [ "Other information • each 5 mL contains : sodium 3 mg • store at 20-25 ° C (68-77 ° F) • do not use if printed neckband is broken or missing" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate" ], "questions": [ "Questions or comments? 1-888-547-7400" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Compare to active ingredient in Children’s Tylenol® Oral Suspension For Ages 2 to 11 Years Dye-Free Children’s Acetaminophen 160 mg / 5 mL Oral Suspension Fever Reducer / Pain Reliever • Alcohol, ibuprofen and aspirin free • Paraben free Cherry Flavor Ages 2 to 11 Years Dosage Cup Included up&up ™ 8 FL OZ (237 mL) up&up-childrens-acetaminophen-cherry-carton-image.jpg" ], "set_id": "e2989ead-7fdc-4295-bf94-423195775670", "id": "a7b3cd92-d091-458e-b8b6-882b59db7554", "effective_time": "20260908", "version": "2", "openfda": { "application_number": [ "M013" ], "brand_name": [ "UP AND UP CHILDRENS ACETAMINOPHEN" ], "generic_name": [ "ACETAMINOPHEN" ], "manufacturer_name": [ "Target Corporation" ], "product_ndc": [ "82442-151" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN" ], "rxcui": [ "307668" ], "spl_id": [ "a7b3cd92-d091-458e-b8b6-882b59db7554" ], "spl_set_id": [ "e2989ead-7fdc-4295-bf94-423195775670" ], "package_ndc": [ "82442-151-01", "82442-151-34" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D" ] } } ] }