Drugplain

Dimetapp Cold and Allergy 1 mg/5mL

BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE · ELIXIR · Foundation Consumer Brands

No Recall History
Plain English

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

Key Facts

Brand Name
Dimetapp Cold and Allergy
Generic Name
BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE
NDC Code (Product)
80070-300
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 accident124 reports
haemorrhagic stroke31 reports
convulsion25 reports
drug hypersensitivity18 reports
injury16 reports
headache15 reports
hemiparesis15 reports
hypertension14 reports
amnesia12 reports
aneurysm12 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves: runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever

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 Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema, asthma, or chronic bronchitis Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers When using this product do not use more than directed drowsiness may occur 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 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.

Frequently Asked Questions

What is Dimetapp Cold and Allergy used for?

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

Is Dimetapp Cold and Allergy a controlled substance?

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

What is the generic name for Dimetapp Cold and Allergy?

The generic name for Dimetapp Cold and Allergy is BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE. There are no other listed brand versions of BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE.

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

The NDC (National Drug Code) for Dimetapp Cold and Allergy 1 mg/5mL is 80070-300, listed by Foundation Consumer Brands.

Product NDC

80070-300

Package NDC

80070-300-04

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

Data from openFDA · Public domain (CC0 1.0)