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西药 · 美国药品标签原文

Severe Sinus Congestion and Pain

ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE

Severe Sinus Congestion and Pain · Shield Pharmaceuticals Corp。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

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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

Active ingredients (in each caplet) Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

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

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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>&#x2022; take 2 caplets every 4 hours &#x2022; swallow whole; do not crush, chew or dissolve &#x2022; 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.
核对原始来源