说明与适用边界
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spl product data elements
COLDTAC ULTRA Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE STARCH, CORN SODIUM BENZOATE SODIUM STARCH GLYCOLATE TYPE A TALC SILICON DIOXIDE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED A15
活性成分 / Active ingredient
ACTIVE INGREDIENTS (in each tablet) Acetaminophen 500 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg
用途 / Purpose
PURPOSE Pain Reliever/Fever Reducer Antihistamine Nasal decongestant
适应证 / Indications and usage
Uses: temporarily relieves these symptoms of hay fever or other respiratory allergies: headache sinus congestion & pressure nasal congestion runny nose and sneezing minor aches & pain temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages
警告 / Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take : more than 6 tablets in 24 hours, which is the maximum daily amount for this product with other drugs contains acetaminophen 3 or more alcoholic drinks every day while using this product. 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 doctor promptly 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 to make a child sleepy Ask a doctor before use if you have: liver disease heart disease high blood pressure thyroid disease glaucoma diabetes trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are: taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product: do not use more than directed 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: nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or last 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: ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. 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.
禁用事项 / 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 to make a child sleepy
咨询医生 / Ask a doctor
Ask a doctor before use if you have: liver disease heart disease high blood pressure thyroid disease glaucoma diabetes trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis
咨询医药人员 / Ask a doctor or pharmacist
使用中 / When using
When using this product: do not use more than directed 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
停用事项 / Stop use
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 last more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding: ask a health professional before use.
儿童安全 / Keep out of reach of children
Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. 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.
用法用量原文 / Dosage and administration
Directions: Do not take more than directed - see overdose warning Swallow whole; do not crush, chew or dissolve Do not exceed 6 tablets per 24 hours Adults and children 12 years of age & over 1 tablet with water every 4-6 hours as needed Children 4 to 12 years of age Ask a doctor Children under 4 years of age Do not use
dosage and administration table
<table border="0" width="100%"><tbody><tr><td>Adults and children 12 years of age & over</td><td>1 tablet with water every 4-6 hours as needed</td></tr><tr><td>Children 4 to 12 years of age</td><td>Ask a doctor</td></tr><tr><td>Children under 4 years of age</td><td>Do not use</td></tr></tbody></table>
其他安全资料 / Other safety information
Other information: Store at room temperature between 25°C (77°F); excursions permitted between 15°C-30°C (59°F-86°F) Avoid excessive heat and humidity Tamper Evident: do not use if package or blister unit is open or shows any sign of tampering
辅料 / Inactive ingredients
Inactive ingredients: Microcrystalline cellulose, Polyvinylpyrrolidone, Crospovidone, Magnesium stearate, Colloidal silicon dioxide, Purified talc. Inactive ingredients : magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc.
questions
Questions or comments? Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us
spl unclassified section
Exclusively distributed by: OPMX San Diego, CA 92154 Phone: 619-600-5632
package label principal display panel
PRINCIPAL DISPLAY PANEL - 144 TABLETS NDC 69729-133-38 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat 144 Tablets (72 Packs of 2 tablets) Cold144
PRINCIPAL DISPLAY PANEL - 12 TABLETS NDC 69729-133-37 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat 12 Tablets (6 Packs of 2 tablets) BOX 37 ESP
PRINCIPAL DISPLAY PANEL - 6 TABLETS NDC 69729-133-06 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat 6 Tablets (3 Packs of 2 tablets) BOX2-3 ESP
PRINCIPAL DISPLAY PANEL - 2 TABLETS NDC 69729-133-27 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat 2 Tablets Cold2
PRINCIPAL DISPLAY PANEL - 100 TABLETS NDC 69729-133-50 COLDTAC ULTRA Actaminophen 500 mg / Pain reliever Chlorpheniramine Maleate 4 mg / Antihistamine Phenylephrine HCl 10 mg / Nasal decongestant Cold & Flu Relief Medicine Alivia los Sintomas de GRIPE y RESFRIADO 100 Tablets / Tabletas 50 Packs / Sobres 2 Tablets / Tabletas BOX100
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 5 / 20260724
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

