说明与适用边界
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spl product data elements
Mucus Relief Guaifenesin GUAIFENESIN GUAIFENESIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE HYPROMELLOSE, UNSPECIFIED CELLULOSE, MICROCRYSTALLINE POVIDONE, UNSPECIFIED G233
活性成分 / Active ingredient
ACTIVE INGREDIENT(in each extended-release tablet) Guaifenesin 600 mg
用途 / Purpose
PURPOSE Expectorant
适应证 / Indications and usage
USE(S) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
警告 / Warnings
WARNING .
禁用事项 / Do not use
DO NOT USE for children under 12 years of age
咨询医生 / Ask a doctor
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
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
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 crush, chew, or break 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 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use
储存 / Storage and handling
OTHER INFORMATION tamper evident: do not use if seal on the bottle printed "SEALED for YOU PROTECTION" is broken or missing. store between 20 to 25°C (68 to 77°F)
辅料 / Inactive ingredients
INACTIVE INGREDIENTS carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone
spl unclassified section
QUESTIONS? 1-800-616-2471 You may also report side effects to this phone number.
Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 600 mg 12 71610-499-12 60 71610-499-53 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20201217JH Aphena Pharma Solutions - TN
spl unclassified section table
<table border="0" cellpadding="1" cellspacing="1" width="28%"><colgroup><col width="10%"/><col/></colgroup><tbody><tr styleCode="Toprule"><td valign="bottom" align="center" styleCode="bold">Count</td><td valign="bottom" align="center"><content styleCode="bold">600 mg</content></td></tr><tr><td valign="bottom" align="center">12</td><td align="center">71610-499-12</td></tr><tr><td valign="bottom" align="center">60</td><td align="center">71610-499-53</td></tr></tbody></table>
package label principal display panel
PRINCIPAL DISPLAY PANEL - 600 mg NDC 71610-499 - Guaifenesin ER 600 mg Tablets Bottle Label 600 mg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20210503
- 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.

