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西药 · 美国药品标签原文

愈创甘油醚 · 愈创甘油醚 · Guaifenesin Extended Release 600 mg / Guaifenesin Extended Release 1200 mg

GUAIFENESIN

Guaifenesin Extended Release 600 mg / Guaifenesin Extended Release 1200 mg · TIME CAP LABORATORIES, 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

Guaifenesin Extended Release 600 mg Guaifenesin SILICON DIOXIDE COPOVIDONE K25-31 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE 102 POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID FD&C BLUE NO. 1 ALUMINUM LAKE GUAIFENESIN GUAIFENESIN Blue and White 42 Guaifenesin Extended Release 1200 mg Guaifenesin SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE 102 POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID FD&C BLUE NO. 1 ALUMINUM LAKE COPOVIDONE K25-31 GUAIFENESIN GUAIFENESIN Blue and White 41

活性成分 / Active ingredient

OTC - ACTIVE INGREDIENT SECTION For 600 mg: Active ingredient (in each extended-release tablet) Guaifenesin, USP 600 mg For 1200 mg: Active ingredient (in each extended-release tablet) Guaifenesin, USP 1200 mg

用途 / Purpose

OTC - PURPOSE SECTION Purpose Expectorant

适应证 / Indications and usage

INDICATIONS & USAGE SECTION Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

警告 / Warnings

WARNINGS SECTION

禁用事项 / Do not use

OTC - DO NOT USE SECTION Do not use • for children under 12 years of age

咨询医生 / Ask a doctor

OTC - ASK DOCTOR SECTION Ask a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus)

停用事项 / Stop use

OTC - STOP USE SECTION Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

孕哺期 / Pregnancy or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION If pregnant or breast-feeding, ask a health professional before use.

儿童安全 / Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

用法用量原文 / Dosage and administration

DOSAGE & ADMINISTRATION SECTION Directions For 600 mg • do not crush, chew, or break extended - release tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over: 1 or 2 extended - release tablets every 12 hours. Do not exceed 4 extended - release tablets in 24 hours. • children under 12 years of age: do not use For 1200 mg • do not crush, chew, or break extended - release tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over: 1 extended - release tablet every 12 hours. Do not exceed 2 extended - release tablets in 24 hours. • children under 12 years of age: do not use

储存 / Storage and handling

STORAGE AND HANDLING SECTION Other information • store at 20-25°C (68-77°F)

辅料 / Inactive ingredients

INACTIVE INGREDIENT SECTION Inactive ingredients colloidal silicon dioxide, copovidone, FD&C blue No. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid

questions

OTC - QUESTIONS SECTION Questions or comments? Call 1-877-290-4008

package label principal display panel

PRINCIPAL DISPLAY PANEL guaifenesin-1200mg-70ct-label guaifenesin-600mg-500ct-label

来源、版本与许可

资料类型
美国药品标签原文
版本
1 / 20240207
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