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西药 · 美国药品标签原文

Allergy plus Sinus Headache

ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG

Allergy plus Sinus Headache · 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

Allergy plus Sinus Headache Acetaminophen 325 mg, Diphenhydramine HCl 12.5 mg, Phenylephrine HCl 5 mg STARCH, CORN CROSCARMELLOSE SODIUM POVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE 44;464;SD36

spl unclassified section

Drug Facts TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: Shield Pharmaceuticals Corp. Ronkonkoma, NY 11779

活性成分 / Active ingredient

Active ingredient (in each liquid-filled capsule) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg

用途 / Purpose

Purpose Pain reliever Antihistamine Nasal decongestant

适应证 / Indications and usage

Uses temporarily relieves these symptoms of hay fever and the common cold: runny nose sneezing headache minor aches and pains nasal congestion temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes

警告 / Warnings

Warnings Liver warning: This product contains acetaminophen. 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 hives facial swelling asthma (wheezing) shock 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. with any other product containing diphenhydramine, even one used on skin 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 acetaminophen, ask a doctor or pharmacist.

咨询医生 / Ask a doctor

Ask a doctor before use if you have liver disease glaucoma thyroid disease heart disease diabetes high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis

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 taking sedatives or tranquilizers

使用中 / When using

When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages

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 new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present

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 . In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

用法用量原文 / Dosage and administration

Directions do not use more than directed adults and children 12 years and over: take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

其他安全资料 / Other safety information

Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

辅料 / Inactive ingredients

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, povidone*, pregelatinized starch, stearic acid powder, talc, titanium dioxide *may contain these ingredients

questions

Questions or comments? 1-800-373-6981 (toll-free)

package label principal display panel

PRINCIPAL DISPLAY PANEL Allergy plus Sinus headache Acetaminophen Diphenhydramine HCl Phenylephrine HCl Pain reliever / Antihistamine / Nasal decongestant Relieves: runny nose • sneezing • headache • minor aches and pains • hay fever • nasal congestion • itching of the nose or throat • itchy, watery eyes Carton Carton

来源、版本与许可

资料类型
美国药品标签原文
版本
2 / 20251107
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