Drugplain

Childrens Robitussin 12 Hour Cough Relief 30 mg/5mL

dextromethorphan polistirex · SUSPENSION, EXTENDED RELEASE · Haleon US Holdings LLC

No Recall History
Plain English

Childrens Robitussin 12 Hour Cough Relief is a suspension, extended release containing dextromethorphan polistirex at 30 mg/5mL, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
Childrens Robitussin 12 Hour Cough Relief
Generic Name
dextromethorphan polistirex
NDC Code (Product)
0031-8725
Manufacturer
Haleon US Holdings LLC
Strength
30 mg/5mL
Dosage Form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA091135
Marketing Start
07/05/2016

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective273 reports
diarrhoea66 reports
dizziness39 reports
drug effect incomplete33 reports
nausea27 reports
hypersensitivity26 reports
incorrect dose administered25 reports
condition aggravated24 reports
somnolence23 reports
vomiting19 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep

Dosage & Administration

Directions shake bottle well before use measure only with dosing cup provided. Do not use dosing cup with other products dose as follows or as directed by doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use

Warnings

Warnings Do not use if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Allergy Alert Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. Ask a doctor before use if you have chronic cough that lasts as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088. cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. 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.

Frequently Asked Questions

What is Childrens Robitussin 12 Hour Cough Relief used for?

Childrens Robitussin 12 Hour Cough Relief contains dextromethorphan polistirex. It is a suspension, extended release taken oral. Consult your doctor for specific uses.

Is Childrens Robitussin 12 Hour Cough Relief a controlled substance?

Childrens Robitussin 12 Hour Cough Relief is not classified as a controlled substance by the DEA.

What is the generic name for Childrens Robitussin 12 Hour Cough Relief?

The generic name for Childrens Robitussin 12 Hour Cough Relief is dextromethorphan polistirex. There are 12 other brand versions of dextromethorphan polistirex.

What is the NDC code for Childrens Robitussin 12 Hour Cough Relief 30 mg/5mL?

The NDC (National Drug Code) for Childrens Robitussin 12 Hour Cough Relief 30 mg/5mL is 0031-8725, listed by Haleon US Holdings LLC.