{ "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": [ "TEXACLEAR PAIN RELIEVER Caffeine, Choline salicylate ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SACCHARIN SODIUM SORBITOL CHOLINE SALICYLATE SALICYLIC ACID CAFFEINE CAFFEINE" ], "spl_unclassified_section": [ "TEXACLEAR Pain Reliever ( choline salicylate & caffeine), solution GM Pharmaceuticals, Inc. -- TexaClear Pain Reliever Drug Facts Drug Facts" ], "active_ingredient": [ "Active Ingredients per 30mL Caffeine 65 mg Choline Salicylate (NSAID)* 870 mg" ], "purpose": [ "Purpose Pain Reliever Aid Pain Reliever / Fever Reducer ( NSAID) *nonsteroidal anti-inflammatory drug" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: ○ headache ○ minor arthritis pain ○ muscle aches ○ menstrual cramps ○ backache temporarily reduces fever" ], "warnings": [ "Warnings Reye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert Salicylates (NSAIDs) may cause a severe allergic reaction which may include: hives skin reddening rash facial swelling shock asthma (wheezing) Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/ fever reducer. Ask a doctor before use if stomach bleeding warning applies to you you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have a history of stomach problems such as heartburn, upset stomach, stomach pain, or ulcers you have asthma Ask a doctor or pharmacist before use if under a doctor's care for any serious condition taking a prescription drug for diabetes, gout, or arthritis. When using this product limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat the recommended dose of this product contains about as much caffeine as a cup of coffee take with food or milk if stomach upset occurs Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: ○ feel faint ○ vomit blood ○ have bloody or black stools ○ have stomach pain that does not get better symptoms do not improve pain gets worse or lasts more than 10 days ringing in the ears or loss of hearing occurs redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "Do not use if you ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/ fever reducer." ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have a history of stomach problems such as heartburn, upset stomach, stomach pain, or ulcers you have asthma" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if under a doctor's care for any serious condition taking a prescription drug for diabetes, gout, or arthritis." ], "when_using": [ "When using this product limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat the recommended dose of this product contains about as much caffeine as a cup of coffee take with food or milk if stomach upset occurs" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: ○ feel faint ○ vomit blood ○ have bloody or black stools ○ have stomach pain that does not get better symptoms do not improve pain gets worse or lasts more than 10 days ringing in the ears or loss of hearing occurs redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days" ], "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." ], "dosage_and_administration": [ "Directions do not take more than directed. adults and children 12 years of age and over: take 30mL every 6 hours, while symptoms persist do not take exceed 4 doses in any 24 hours unless directed by a doctor children under 12 years of age: ask a doctor use enclosed dose cup" ], "other_safety_information": [ "Other Information each 30mL contains: Sodium 19 mg read all product information before using store at room temperature 68-86ºF (20-30ºC) avoid excessive heat and humidity tamper evident: Do not use if foil seal under cap is broken or missing read all" ], "inactive_ingredient": [ "Inactive Ingredients anhydrous citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol" ], "questions": [ "Questions or comments? Call 1-888-423-0139 R071316M" ], "recent_major_changes": [ "" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 58809-389-08 TEXACLEAR Pain Reliever 8 fl oz (237 mL) principaldisplaylabel Onsert2" ], "set_id": "065bd10c-3bcf-486f-a49c-40544127007f", "id": "4139160a-f694-24ee-e063-6294a90a1f52", "effective_time": "20251015", "version": "10", "openfda": { "application_number": [ "M013" ], "brand_name": [ "TEXACLEAR PAIN RELIEVER" ], "generic_name": [ "CAFFEINE, CHOLINE SALICYLATE" ], "manufacturer_name": [ "GM Pharmaceuticals, INC" ], "product_ndc": [ "58809-389" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CAFFEINE", "CHOLINE SALICYLATE" ], "rxcui": [ "1994320" ], "spl_id": [ "4139160a-f694-24ee-e063-6294a90a1f52" ], "spl_set_id": [ "065bd10c-3bcf-486f-a49c-40544127007f" ], "package_ndc": [ "58809-389-08" ], "is_original_packager": [ true ], "upc": [ "0358809389087" ], "nui": [ "N0000175739", "N0000175729", "N0000175790", "M0023046" ], "pharm_class_epc": [ "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]" ], "pharm_class_pe": [ "Central Nervous System Stimulation [PE]" ], "pharm_class_cs": [ "Xanthines [CS]" ], "unii": [ "3G6A5W338E", "KD510K1IQW" ] } } ] }