说明与适用边界
此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。
spl product data elements
Severe Sinus Congestion and Pain Acetaminophen, Guaifenesin, Phenylephrine CROSCARMELLOSE SODIUM SILICON DIOXIDE DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSES MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE WATER STARCH, CORN TALC TITANIUM DIOXIDE CROSPOVIDONE MALTODEXTRIN SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SD32;44;527
spl unclassified section
Drug Facts
Distributed by: Shield Pharmaceuticals Corp. Ronkonkoma, NY 11779
活性成分 / Active ingredient
用途 / Purpose
Purpose Pain reliever/fever reducer Expectorant Nasal decongestant
适应证 / 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
警告 / Warnings
Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing 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.
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.
咨询医生 / Ask a 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)
咨询医药人员 / Ask a doctor or pharmacist
使用中 / When using
When using this product do not exceed recommended dose
停用事项 / 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.
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.
过量 / Overdosage
Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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) adults and children 12 years and over • take 2 caplets every 4 hours • swallow whole; do not crush, chew or dissolve • do not take more than 10 caplets in 24 hours children under 12 years ask a doctor
dosage and administration table
<table width="100%"><tbody><tr><td>adults and children 12 years and over</td><td>• take 2 caplets every 4 hours • swallow whole; do not crush, chew or dissolve • do not take more than 10 caplets in 24 hours </td></tr><tr><td>children under 12 years</td><td>ask a doctor</td></tr></tbody></table>
其他安全资料 / Other safety information
Other information • store between 20-25° C (68-77° F)
questions
Questions or comments? 1-800-373-6981 (toll-free)
辅料 / Inactive ingredients
Inactive ingredients croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol , polyvinyl alcohol, povidone, purified water, starch, talc, titanium dioxide
package label principal display panel
PRINCIPAL DISPLAY PANEL Compare to the active ingredients in Tylenol® Sinus Severe Severe Sinus Congestion & Pain Acetaminophen, Guaifenesin, Phenylephrine HCl Carton Carton
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20251108
- 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.

