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西药 · 美国药品标签原文

VanaCof 2

CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATE

VanaCof 2 · GM Pharmaceuticals, INC。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

VanaCof 2 Chlophedianol HCl, Dexchlorpheniramine Maleate WATER PROPYLENE GLYCOL SODIUM BENZOATE SORBITOL SOLUTION DEXCHLORPHENIRAMINE MALEATE DEXCHLORPHENIRAMINE CHLOPHEDIANOL HYDROCHLORIDE CHLOPHEDIANOL ANHYDROUS CITRIC ACID SUCRALOSE GLYCERIN TRISODIUM CITRATE DIHYDRATE

活性成分 / Active ingredient

Active ingredients in each 5 mL (1 teaspoonful) Chlophedianol HCI 12.5 mg Dexchlorpheniramine Maleate 1 mg

用途 / Purpose

Purpose Cough Suppressant Antihistamine

适应证 / Indications and usage

Uses ■ temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes ■ cough due to minor throat and bronchial irritation

警告 / Warnings

Warnings Ask a doctor before use if you have ■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema ■ a cough that occurs with too much phlegm (mucus) ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland ■ glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product ■ excitability may occur, especially in children ■ may cause marked drowsiness ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect ■ avoid alcoholic drinks ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. ■ new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

咨询医生 / Ask a doctor

Ask a doctor before use if you have ■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema ■ a cough that occurs with too much phlegm (mucus) ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland ■ glaucoma

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

使用中 / When using

When using this product ■ excitability may occur, especially in children ■ may cause marked drowsiness ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect ■ avoid alcoholic drinks ■ use caution when driving a motor vehicle or operating machinery

停用事项 / Stop use

Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. ■ new symptoms occur

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.

用法用量原文 / Dosage and administration

Directions do not exceed recommended dosage. adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls (40 mL) in 24 hours. children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours. children under 6 years of age: consult a doctor.

dosage and administration table

<table border="1" cellpadding="1" cellspacing="1" width="100%"><tbody><tr><td>adults and children 12 years of age and over:</td><td><paragraph>2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls (40 mL) in 24 hours. </paragraph></td></tr><tr><td>children 6 to under 12 years of age:</td><td><paragraph>1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours. </paragraph></td></tr><tr><td>children under 6 years of age:</td><td>consult a doctor.</td></tr></tbody></table>

储存 / Storage and handling

Other information ■ this packaging is child-resistant. ■ store at room temperature of 68°-86°F (20°-30°C) with excursions of 59°-86°F (15°-30°C)

辅料 / Inactive ingredients

Inactive ingredients citric acid anhydrous, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose

questions

Questions? Call 1-888-535-0305 9a.m. - 5p.m. CST

spl unclassified section

Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX 76118

package label principal display panel

NDC 58809-190-16 VanaCof® 2 EACH 5 mL (1 TEASPOONFUL) CONTAINS: Chlophedianol HCI..........................12.5 mg Dexchlorpheniramine Maleate............1 mg Cough Suppressant Antihistamine Sugar Free, Alcohol Free, Dye Free Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER. Dispense in a tight, light-resistant container with a child-resistant cap. US Patent # 9,463,191 US Patent # 9,050,289 GM Pharmaceuticals, Inc. 16 fl. oz. (473 mL) VanaCof 2 Label

来源、版本与许可

资料类型
美国药品标签原文
版本
5 / 20260108
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