说明与适用边界
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spl product data elements
Childrens Mucus and Cough Relief GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 POTASSIUM CITRATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant
active ingredient table
<table width="70%"><col width="42%"/><col width="28%"/><tbody><tr><td styleCode="Toprule " valign="top"><paragraph><content styleCode="bold"><content styleCode="italics">Active ingredients (in each 5 mL)</content></content></paragraph></td><td styleCode="Toprule " valign="top"><paragraph><content styleCode="bold"><content styleCode="italics">Purposes</content></content></paragraph></td></tr><tr><td valign="top"><paragraph>Dextromethorphan HBr 5 mg</paragraph></td><td valign="top"><paragraph>Cough suppressant</paragraph></td></tr><tr><td styleCode="Botrule " valign="top"><paragraph>Guaifenesin 100 mg</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>Expectorant</paragraph></td></tr></tbody></table>
用途 / Purpose
Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant
purpose table
<table width="70%"><col width="42%"/><col width="28%"/><tbody><tr><td styleCode="Toprule " valign="top"><paragraph><content styleCode="bold"><content styleCode="italics">Active ingredients (in each 5 mL)</content></content></paragraph></td><td styleCode="Toprule " valign="top"><paragraph><content styleCode="bold"><content styleCode="italics">Purposes</content></content></paragraph></td></tr><tr><td valign="top"><paragraph>Dextromethorphan HBr 5 mg</paragraph></td><td valign="top"><paragraph>Cough suppressant</paragraph></td></tr><tr><td styleCode="Botrule " valign="top"><paragraph>Guaifenesin 100 mg</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>Expectorant</paragraph></td></tr></tbody></table>
适应证 / Indications and usage
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep
警告 / Warnings
Warnings Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
禁用事项 / Do not use
Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
咨询医生 / Ask a doctor
Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma
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.
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 at 1-800-222-1222.
用法用量原文 / Dosage and administration
Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products mL = milliliter Age Dose children 6 years to under 12 years 5 mL – 10 mL every 4 hours children 4 years to under 6 years 2.5 mL – 5 mL every 4 hours children under 4 years do not use
dosage and administration table
<table width="70%"><col width="36%"/><col width="35%"/><thead><tr><th align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Age</content></th><th align="center" styleCode="Rrule Botrule Toprule " valign="top"><content styleCode="bold">Dose</content></th></tr></thead><tbody><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>children 6 years to under 12 years</paragraph></td><td styleCode="Rrule Toprule Botrule " valign="top"><paragraph>5 mL – 10 mL every 4 hours</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children 4 years to under 6 years</paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph>2.5 mL – 5 mL every 4 hours</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>children under 4 years</paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph>do not use</paragraph></td></tr></tbody></table>
储存 / Storage and handling
Other information each 5 mL contains: sodium 3 mg Tamper -evident: do not use if printed inner seal under cap is torn or missing store at room temperature do not refrigerate dosing cup provided
辅料 / Inactive ingredients
Inactive ingredients Anhydrous citric acid, edetate disodium, FD&C Red#40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
package label principal display panel
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton NDC 63868-771-04 Compare to the Active ingredient in Children’s Mucinex Cough* Children's Mucus &Cough Relief Cough Suppressant Expectorant Dextromethorphan HBr Guaifenesin Each Dose of Cherry Flavored Children's Mucus & Cough Relief: Controls Cough Relieves Chest Congestion Breaks up Mucus Alcohol-free See New Dosing information Cherry Flavor 4 FL OZ (118 mL) IMPORTANT: Keep this carton for future reference on full labeling. DOSAGE CUP INCLUDED Distributed by C.D.M.A., Inc© 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com Questions: 248-449-9300 *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex.® QC 100% Satisfaction Guaranteed. Quality Choice Children's Mucus and Cough Relief Cherry Flavor 4 FL OZ
package label principal display panel table
<table width="100%"><col width="100%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>IMPORTANT: Keep this carton for future reference on full labeling.</paragraph></td></tr></tbody></table>
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 8 / 20251204
- 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.

