{ "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": 1 } }, "results": [ { "spl_product_data_elements": [ "AXIV Sinus Severe Mucus Acetaminophen, Guaifenesin, Phenylephrine Hydrocloride PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PROPYLPARABEN GLYCERIN FD&C RED NO. 40 D&C RED NO. 33 GELATIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL WATER TITANIUM DIOXIDE SORBITOL GUAIFENESIN GUAIFENESIN ACETAMINOPHEN ACETAMINOPHEN METHYLPARABEN POVIDONE K30 AXIV" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: VIVUNT PHARMA LLC 8950 SW 74th. Court. Suite 1901 Miami, Florida, 33156-3178 Made in India www.vivunt.live" ], "active_ingredient": [ "Active Ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain reliever-Fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant" ], "active_ingredient_table": [ "
Active Ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain reliever-Fever reducer
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
" ], "purpose": [ "Active Ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain reliever-Fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant" ], "purpose_table": [ "
Active Ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain reliever-Fever reducer
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: sinus congestion and pressure headache nasal congestion minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours 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 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion or cough 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 cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition Keep out of reach of children Keep out of reach of children. If pregnant or breast-feeding ask a health professional before use. Overdose warning In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately." ], "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. if you have ever had an allergic reaction to this product or any of its ingredients" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "when_using": [ "When using this product do not exceed recommended dose" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion or cough 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 cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use." ], "dosage_and_administration": [ "Directions Take only as directed (see overdose warning) Do not take more than 8 softgels in 24 hours adults and children 12 years and over 2 softgels with water every 4 hours children 4 to under 12 years consult a doctor children under 4 years do not use" ], "dosage_and_administration_table": [ "
adults and children 12 years and over2 softgels with water every 4 hours
children 4 to under 12 yearsconsult a doctor
children under 4 yearsdo not use
" ], "storage_and_handling": [ "Other information Store at 20° - 25 °C (68 °- 77 °F) Read all product information before using Tamper Evident: Do not use if carton is open or blister unit is broken. Tamper Evident: Do not use if carton or pouch is open" ], "inactive_ingredient": [ "Inactive ingredients D&C Red No. 33, FD&C Red No. 40, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL-AXIV Sinus Severe + Mucus 100 Compare Vicks® Sinex ™ Severe All In One Sinus + Mucus™ LiquiCaps® active ingredients* NDC 82706-020-03 AXIV Sinus Severe + Mucus Cough & Congestion Pain Reliever Fever Reducer Expectorant Nassal Decongestant NON-DROWSY Acetaminophen, Guaifenesin, Phenylephrine HCl 100 SOFTGELS** **Liquid-filled Capsules *This product is not manufactured or distributed by The Procter &Gamble Company, owner of the registered trademarks Vicks® Sinex ™ Severe All In One Sinus + Mucus™ LiquiCaps® AXIV Sinus Severe 100", "PRINCIPAL DISPLAY PANEL - AXIV Sinus Severe + Mucus 24 Compare Vicks® Sinex ™ Severe All In One Sinus + Mucus™ LiquiCaps® active ingredients* NDC 82706-020-01 AXIV Sinus Severe + Mucus Cough & Congestion Pain Reliever Fever Reducer Expectorant Nassal Decongestant NON-DROWSY Acetaminophen, Guaifenesin, Phenylephrine HCl 24 SOFTGELS** **Liquid-filled Capsules *This product is not manufactured or distributed by The Procter &Gamble Company, owner of the registered trademarks Vicks® Sinex ™ Severe All In One Sinus + Mucus™ LiquiCaps® 7", "PRINCIPAL DISPLAY PANEL - AXIV Sinus Severe + Mucus 50 Compare Vicks® Sinex ™ Severe All In One Sinus + Mucus™ LiquiCaps® active ingredients* NDC 82706-020-04 AXIV Sinus Severe + Mucus Cough & Congestion Pain Reliever Fever Reducer Expectorant Nassal Decongestant NON-DROWSY Acetaminophen, Guaifenesin, Phenylephrine HCl 50 SOFTGELS** **Liquid-filled Capsules *This product is not manufactured or distributed by The Procter &Gamble Company, owner of the registered trademarks Vicks® Sinex ™ Severe All In One Sinus + Mucus™ LiquiCaps® SINUS 50 SOFTGELS" ], "set_id": "13245298-8b78-e177-e063-6294a90a6bec", "id": "3f04ea00-9815-32e5-e063-6294a90a14c6", "effective_time": "20250917", "version": "6", "openfda": { "application_number": [ "M012" ], "brand_name": [ "AXIV Sinus Severe Mucus" ], "generic_name": [ "ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDE" ], "manufacturer_name": [ "VIVUNT PHARMA LLC" ], "product_ndc": [ "82706-020" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "GUAIFENESIN", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "2049223" ], "spl_id": [ "3f04ea00-9815-32e5-e063-6294a90a14c6" ], "spl_set_id": [ "13245298-8b78-e177-e063-6294a90a6bec" ], "package_ndc": [ "82706-020-01", "82706-020-02", "82706-020-03", "82706-020-04" ], "is_original_packager": [ true ], "upc": [ "0850047780386", "0850047780607" ], "nui": [ "N0000193956", "N0000008867", "N0000009560" ], "pharm_class_epc": [ "Expectorant [EPC]" ], "pharm_class_pe": [ "Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]" ], "unii": [ "362O9ITL9D", "495W7451VQ", "04JA59TNSJ" ] } } ] }