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.

