Drugplain

TOPCO Childrens Cough Relief 5 mg/5mL

DEXTROMETHORPHAN HBr AND GUAIFENESIN · LIQUID · Topco Associates, LLC

No Recall History
Plain English

TOPCO Childrens Cough Relief is a liquid containing dextromethorphan hbr and guaifenesin at 5 mg/5mL, taken oral. Manufactured by Topco Associates, LLC.

Key Facts

Brand Name
TOPCO Childrens Cough Relief
Generic Name
DEXTROMETHORPHAN HBr AND GUAIFENESIN
NDC Code (Product)
76162-751
Manufacturer
Topco Associates, LLC
Strength
5 mg/5mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
10/21/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

cardiac arrest5 reports
respiratory arrest5 reports
intentional drug misuse2 reports
arrhythmia supraventricular1 reports
completed suicide1 reports
confusional state1 reports
device information output issue1 reports
device use confusion1 reports
discomfort1 reports
dizziness1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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

Dosage & Administration

Directions do not give more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Age Dose children 6 years to under 12 years of age 5 mL – 10 mL every 4 hours children 4 years to under 6 years of age 2.5 mL – 5 mL every 4 hours children under 4 years do not use

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 When Using this product do not use more than directed 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 condition. 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.

Frequently Asked Questions

What is TOPCO Childrens Cough Relief used for?

TOPCO Childrens Cough Relief contains DEXTROMETHORPHAN HBr AND GUAIFENESIN. It is a liquid taken oral. Consult your doctor for specific uses.

Is TOPCO Childrens Cough Relief a controlled substance?

TOPCO Childrens Cough Relief is not classified as a controlled substance by the DEA.

What is the generic name for TOPCO Childrens Cough Relief?

The generic name for TOPCO Childrens Cough Relief is DEXTROMETHORPHAN HBr AND GUAIFENESIN. There are 11 other brand versions of DEXTROMETHORPHAN HBr AND GUAIFENESIN.

What is the NDC code for TOPCO Childrens Cough Relief 5 mg/5mL?

The NDC (National Drug Code) for TOPCO Childrens Cough Relief 5 mg/5mL is 76162-751, listed by Topco Associates, LLC.