{ "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": "2026-06-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Calmour Childrens Acetaminophen Strips Chewable Acetaminophen Oral Chewable 80 mg ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID GLYCERIN HYDROXYPROPYL BETADEX HYPROMELLOSE, UNSPECIFIED FD&C YELLOW NO. 6 ORANGE PEPPERMINT POLYSORBATE 80 PULLULAN SODIUM CARBONATE SUCRALOSE XYLITOL AMMONIUM GLYCYRRHIZATE HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)" ], "drug_and_or_laboratory_test_interactions": [ "Children's Acetaminophen Chewable Strips" ], "description": [ "Drug Facts" ], "active_ingredient": [ "Active ingredient (in each strip) Acetaminophen 80 mg" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "indications_and_usage": [ "Uses Temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■ flu ■ the common cold ■ 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 non-prescription). 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: new symptoms occur redness or swelling is present pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days 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 (1-800-222-1222) right away. 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) find the right dose on the chart below. If possible, use weight to dose; otherwise, use age. remove the strip from the pouch, place in the child's mouth then wait for 45 seconds, and anything remaining can be chewed. repeat dose every 4-6 hours while symptoms last do not give more than 5 doses in 24 hours Dosing Chart Wt: weight; lb: pound; mg: milligram * or as directed by a doctor Age in Years Wt in lbs Number of strips given every 4-6 hours of acetaminophen 80 mg* under 2 years < 24 lbs consult a doctor 2 to under 4 years 24-35 lbs 2 strips of 80 mg 4 to under 6 years 36-47 lbs 3 strips of 80 mg 6 to under 9 years 48-59 lbs 4 strips of 80 mg image" ], "dosage_and_administration_table": [ "
Dosing Chart
Wt: weight; lb: pound; mg: milligram
* or as directed by a doctor
Age in Years Wt in lbs Number of strips given every 4-6 hours of acetaminophen 80 mg*
under 2 years < 24 lbs consult a doctor
2 to under 4 years 24-35 lbs 2 strips of 80 mg
4 to under 6 years 36-47 lbs 3 strips of 80 mg
6 to under 9 years 48-59 lbs 4 strips of 80 mg
" ], "keep_out_of_reach_of_children": [ "Other information store below 77°F (25°C) do not refrigerate do not use it if the pouch containing strip is open see lot number and expiration date on pouch containing strip and box" ], "inactive_ingredient": [ "Inactive ingredients citric acid anhydrous, glycerin, HP-betacyclodextrin oral, hydroxypropyl methylcellulose, monoammonium glycyrrhizinate, Neelicert FD&C yellow 6, orange flavor, peppermint flavor, polysorbate 80, pregelatinized hydroxypropyl pea starch, pullulan, sodium carbonate, sucralose and xylitol." ], "general_precautions": [ "Questions or comments? Call 1-802-861-4111 Monday-Friday, 9 am-5 pm EST Distributed by: CALMOUR, LLC 1775 Williston Road South Burlington, VT 05403 Phone (802) 861-4111 Calmourhealth.com ©2024 Calmour, LLC" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Pouch Label NDC 82918-006-01 CHILDREN'S ACETAMINOPHEN STRIP CALMOUR Acetaminophen 80 mg 1 Chewable Strip POUCH LABEL CARTON LABEL NDC 82918-006-24 CHILDREN'S ACETAMINOPHEN STRIPS Oral Chewable Strip ● Pain Reliever ● Fever Reducer ● For Ages 2-9 Years ACETAMINOPHEN 80 mg Aspirin Free Ibuprofen Free Alcohol Free 24 Strips (packed individually) CARTON LABEL CARTON LABEL NDC 82918-006-36 CHILDREN'S ACETAMINOPHEN STRIPS Oral Chewable Strip ● Pain Reliever ● Fever Reducer ● For Ages 2-9 Years ACETAMINOPHEN 80 mg Aspirin Free Ibuprofen Free Alcohol Free 36 Strips (packed individually) CARTON LABEL 1 Chewable Strip 24 STRIPS 36 STRIPS" ], "set_id": "ae47b027-4f29-45bb-a8bd-812978932835", "id": "2a5a0639-c514-472f-89ac-6baf8ae2f5f0", "effective_time": "20250222", "version": "1", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Calmour Childrens Acetaminophen Strips Chewable" ], "generic_name": [ "ACETAMINOPHEN ORAL CHEWABLE 80 MG" ], "manufacturer_name": [ "Calmour" ], "product_ndc": [ "82918-006" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN" ], "rxcui": [ "2705808" ], "spl_id": [ "2a5a0639-c514-472f-89ac-6baf8ae2f5f0" ], "spl_set_id": [ "ae47b027-4f29-45bb-a8bd-812978932835" ], "package_ndc": [ "82918-006-01", "82918-006-36", "82918-006-24" ], "is_original_packager": [ true ], "upc": [ "0850053563102", "0850053563119" ], "unii": [ "362O9ITL9D" ] } } ] }