Drugplain

Dimetapp Cold and Cough 1 mg/5mL

BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE · ELIXIR · Foundation Consumer Brands

No Recall History
Plain English

Dimetapp Cold and Cough is a elixir containing brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride at 1 mg/5mL, taken oral. Manufactured by Foundation Consumer Brands.

Key Facts

Brand Name
Dimetapp Cold and Cough
Generic Name
BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
NDC Code (Product)
80070-310
Manufacturer
Foundation Consumer Brands
Strength
1 mg/5mL
Dosage Form
ELIXIR
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
09/15/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

cerebrovascular accident123 reports
haemorrhagic stroke31 reports
convulsion23 reports
drug hypersensitivity16 reports
injury16 reports
hemiparesis15 reports
headache14 reports
aneurysm12 reports
dizziness12 reports
hypertension12 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves: runny nose cough sneezing itching of the nose or throat itchy, watery eyes due to hay fever (or other respiratory allergies) temporarily alleviates the intensity of couging

Dosage & Administration

Directions do not take more than 6 doses in any 24-hour period measure only with dosage cup provided keep dosage cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use

Warnings

Warnings Do not use to sedate a child or to make a child sleepy 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. Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant

Frequently Asked Questions

What is Dimetapp Cold and Cough used for?

Dimetapp Cold and Cough contains BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE. It is a elixir taken oral. Consult your doctor for specific uses.

Is Dimetapp Cold and Cough a controlled substance?

Dimetapp Cold and Cough is not classified as a controlled substance by the DEA.

What is the generic name for Dimetapp Cold and Cough?

The generic name for Dimetapp Cold and Cough is BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE. There are 1 other brand versions of BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE.

What is the NDC code for Dimetapp Cold and Cough 1 mg/5mL?

The NDC (National Drug Code) for Dimetapp Cold and Cough 1 mg/5mL is 80070-310, listed by Foundation Consumer Brands.

Product NDC

80070-310

Package NDC

80070-310-04

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)