{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Allergy Sinus, Lil Drug Store acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN CROSPOVIDONE (15 MPA.S AT 5%) STEARIC ACID PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED AZ;275" ], "spl_unclassified_section": [ "Drug Facts ​Drug Facts", "Other information Other information store at room temperature 59-86°F (15-30°C) avoid excessive heat and humidity" ], "active_ingredient": [ "Active ingredients Active ingredients (in each tablet) Acetamionophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine Hydrochloride 5 mg Purpose Purpose Pain reliever Antihistamine Nasal decongestant" ], "purpose": [ "Purpose Purpose Pain reliever Antihistamine Nasal decongestant" ], "indications_and_usage": [ "Uses Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache sinus congestion and pressure nasal congestion runny nose and sneezing minor aches and pains temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus openings and passages" ], "warnings": [ "Warnings ​Warnings Liver warning Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount. with other drugs containing acetaminophen. 3 or more alcoholic drinks every day while using this product. Allergy alert 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. 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 you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor Ask a doctor before use if you have liver disease heart disease glaucoma diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor before use if you are Ask a doctor before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin. When using this product When using this product do not exceed recommended dosage excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. 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 right away. Prompt 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 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 you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "ask_doctor": [ "Ask a doctor Ask a doctor before use if you have liver disease heart disease glaucoma diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis", "Ask a doctor before use if you are Ask a doctor before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin." ], "when_using": [ "When using this product When using this product do not exceed recommended dosage excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "stop_use": [ "Stop use and ask a doctor if Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "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 right away. Prompt 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 Directions do not take more than directed adults and children 12 years and over take 2 tablets every 4 to 6 hours as needed do not take more than 12 tablets in 24 hours or as directed by a doctor children under 12 years of age ask a doctor" ], "dosage_and_administration_table": [ "
adults and children 12 years and overtake 2 tablets every 4 to 6 hours as neededdo not take more than 12 tablets in 24 hours or as directed by a doctor
children under 12 years of ageask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients Inactive ingredients corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid" ], "questions": [ "Questions or comments? Questions or comments? call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)" ], "package_label_principal_display_panel": [ "Allergy Sinus, Lil' Drug Store ® - PDP/Package [caduceus] on the Go PACKS Allergy Sinus [tablets image] Allergy Sinus Acetaminophen , Chlorpheniramine maleate, Phenylephrine hydrochloride Pain Reliever, Antihistamine, Nasal Decongestant Relief of Sinus Congestion & Pressure Nasal Congestion Runny Nose & Sneezing 6 Tablets ​ 3POUHES, 2 TABLETS PER POUCH [Lil' Drug Store logo] PDP/Package" ], "set_id": "1145440e-b37a-6e5e-e063-6294a90ab4a0", "id": "1145440e-b37b-6e5e-e063-6294a90ab4a0", "effective_time": "20240213", "version": "1", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Allergy Sinus, Lil Drug Store" ], "generic_name": [ "ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc." ], "product_ndc": [ "66715-9927" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "CHLORPHENIRAMINE MALEATE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1046781" ], "spl_id": [ "1145440e-b37b-6e5e-e063-6294a90ab4a0" ], "spl_set_id": [ "1145440e-b37a-6e5e-e063-6294a90ab4a0" ], "package_ndc": [ "66715-9927-3" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "V1Q0O9OJ9Z", "04JA59TNSJ" ] } } ] }