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Drug Facts
Distributed by:
Foundation Consumer Brands, LLC
Pittsburgh, PA 15212
Dimetapp Solution
FDA Label NDC 69536-305
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 Healthcare for the product Dimetapp (NDC 69536-305). 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, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredient (in each 10 mL) | Purpose |
|---|---|
| Brompheniramine maleate, 2 mg | Antihistamine |
Uses
- temporarily relieves:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
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
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 1-888-594-0828weekdays 9 AM to 5 PM EST
Principal Display Panel - 118 Ml Bottle Carton
CHILDREN'S
Dimetapp
®
BROMPHENIRAMINE MALEATE (Antihistamine)
PHARMACIST
RECOMMENDED
Cold &
Allergy
Relieves + comforts:
- Runny nose
- Itchy, watery eyes
- Sneezing
- Itchy throat
6+
YRS
4 FL OZ
(118 mL)
Grape Flavor • Alcohol Free
* Please review the disclaimer below.
