{ "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": [ "COLTALIN-DM Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, Phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE HYDROXYPROPYL METHYLCELLULOSE SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO MICROCRYSTALLINE CELLULOSE SHIELDTM" ], "active_ingredient": [ "Active ingredients (in each tablet) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg" ], "purpose": [ "Purpose Pain reliever-fever reducer Antihistamine Cough Suppressant Nasal decongestant" ], "indications_and_usage": [ "Uses ■ temporarily relieves these symptoms due to a cold, the flu, or hay fever: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ runny nose ■ sinus congestion and pressure ■ cough due to minor throat and bronchial irritation ■ sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ promotes nasal and/or sinus drainage" ], "warnings": [ "Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this product child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin rash occurs, stop use and seek medical help right away.", "Do not give to children under 6 years of age unless directed by doctor." ], "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 the user is 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 before use if the user has heart disease high blood pressure diabetes glaucoma liver disease thyroid disease a high fever a breathing problem such as emphysema or chronic bronchitis a persistent cough cough with excessive phlegm (mucus) difficulty in urination due to enlargement of the prostate gland" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the user is ■ taking sedatives or tranquilizers ■ taking the blood thinning drug warfarin" ], "when_using": [ "When using this product ■ do not exceed recommended dosage ■ may cause excitability especially in children ■ do not drive or operate machinery ■ avoid alcoholic beverages ■ may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect" ], "stop_use": [ "Stop use and ask a doctor if ■ pain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) ■ sore throat persists for more than 2 days ■ nasal congestion is accompanied by fever ■ nervousness, dizziness, or sleeplessness occur ■ any of the following occurs (these could be signs of a serious condition): ■ fever gets worse or lasts more than 3 days ■ a severe sore throat ■ sore throat is accompanied or followed by fever, headache, rash, nausea or vomiting ■ redness or swelling is present ■ new symptoms occur ■ cough persists for more than 1 week, tends to recur, or is accompanied by fever rash, or persistent headache" ], "pregnancy_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 children even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions ■ adults and children 12 years of age and over: 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses (12 tablets) in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age: 1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses (5 tablets) in 24 hours, or as directed by a doctor ■ children under 6 of age : consult a doctor" ], "storage_and_handling": [ "Other information ■ keep tightly sealed ■ store between below 25 C (77 F) in a dry place, away from direct sunlight" ], "inactive_ingredient": [ "Inactive ingredients Citric Acid Monohydrate, Hydroxypropyl Methylcellulose, Corn starch, Microcrystalline Cellulose, D&C Yellow No.10 Aluminum Lake, Colloidal silicon dioxide, Magnesium stearate, Sodium Starch Glycolate." ], "questions": [ "Questions or comments? (888) 221-3496 M-F 9 am to 5 pm ■ you may also report serious side effects to this phone number" ], "package_label_principal_display_panel": [ "COLTALIN-DM Safely Sealed NDC 51467-012-01 Acetaminophen - Pain Reliever-Fever Reducer Chlorpheniramine Maleate - Antihistamine Dextromethorphan Hydrobromide - Cough Suppressant Phenylephrine Hydrochloride - Nasal Decongestant Cough, Cold & Flu Multi-Symptom Relief ■ Minor Aches & Pain, Sore Throat ■ Headache, Fever ■ Nasal Congestion, Sinus Pressure/Drainage ■ Cough ■ Sneezing, Runny Nose ■ Itchy, Watery Eyes 24 Tablets In Individually Sealed Strip Aspirin Free IMAGE OF CARTON", "COLTALIN-DM Safely Sealed NDC 51467-012-02 Acetaminophen - Pain Reliever-Fever Reducer Chlorpheniramine Maleate - Antihistamine Dextromethorphan Hydrobromide - Cough Suppressant Phenylephrine Hydrochloride - Nasal Decongestant Cough, Cold & Flu Multi-Symptom Relief ■ Minor Aches & Pain, Sore Throat ■ Headache, Fever ■ Nasal Congestion, Sinus Pressure/Drainage ■ Cough ■ Sneezing, Runny Nose ■ Itchy, Watery Eyes 36 Tablets In Individually Sealed Strip Aspirin Free IMAGE OF CARTON" ], "set_id": "33e1bec0-323b-40b7-809a-cb65a71ad0ce", "id": "5bb2b1bb-0b8f-02a6-e063-6294a90a0763", "effective_time": "20260917", "version": "4", "openfda": { "application_number": [ "M012" ], "brand_name": [ "COLTALIN-DM" ], "generic_name": [ "ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE" ], "manufacturer_name": [ "FORTUNE PHARMACAL COMPANY LIMITED" ], "product_ndc": [ "51467-012" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "CHLORPHENIRAMINE MALEATE", "DEXTROMETHORPHAN HYDROBROMIDE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1086991" ], "spl_id": [ "5bb2b1bb-0b8f-02a6-e063-6294a90a0763" ], "spl_set_id": [ "33e1bec0-323b-40b7-809a-cb65a71ad0ce" ], "package_ndc": [ "51467-012-01", "51467-012-02" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ" ] } } ] }