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Drug Facts
Distributed by:
Foundation Consumer Brands, LLC
Pittsburgh, PA 15212
Dimetapp Elixir
FDA Label NDC 80070-300
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foundation Consumer Brands for the product Dimetapp (NDC 80070-300). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 10 mL) | Purposes |
|---|---|
| Brompheniramine maleate, 2 mg | Antihistamine |
| Phenylephrine HCl, 5 mg | Nasal decongestant |
Uses
- temporarily relieves:
- nasal congestion
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
- temporarily restores freer breathing through the nose
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- 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 beverages
- 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
- nervousness, dizziness or sleeplessness occurs
- symptoms do not get better within 7 days or are accompanied by fever
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
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 |
Other Information
- each 10 mL contains: sodium 6 mg
- store at 20-25°C (68-77°F)
Inactive Ingredients
anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
Questions Or Comments?
Call 1-888-594-0828 weekdays 9 AM to 5 PM EST
Principal Display Panel - 237 Ml Bottle Carton
Children's
Dimetapp®
BROMPHENIRAMINE MALEATE (Antihistamine)
PHENYLEPHRINE HCl (Nasal Decongestant)
Cold
& Allergy
Relieves Nasal Symptoms
✔ Stuffy Nose✔ Runny Nose✔ Sneezing✔ Itchy, Watery Eyes
Plus Other Symptoms
For Ages
6 Yrs.
& Over
8 FL OZ (237 mL) alcohol-free • grape flavor
Principal Display Panel (237 mL Bottle Carton)
* Please review the disclaimer below.
