Other
Dimetapp
®
Nighttime Cold and Cough
Drug Facts
Dimetapp
®
Cold and Cough
Drug Facts
Distributed by:
Foundation Consumer Healthcare, LLC, Pittsburgh, PA 15212
Dimetapp Kit
FDA Label NDC 69536-355
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 69536-355). 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 ingredient (in each 10 mL) | Purpose |
|---|---|
| Diphenhydramine HCl, 12.5 mg | Antihistamine/cough suppressant |
| Active ingredients (in each 10 mL) | Purposes |
|---|---|
| Brompheniramine maleate, 2 mg | Antihistamine |
| Dextromethorphan HBr, 10 mg | Cough suppressant |
Uses
- temporarily relieves:
- cough
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever (or other respiratory allergies)
- relieves the impluse to cough to help you sleep
- temporarily relieves:
- cough
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever (or other respiratory allergies)
- temporarily alleviates the intensity of coughing
Do Not Use
- to sedate a child or to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
- 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
- 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
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
- 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.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
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
- 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 |
| 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 8 mg
- store at 20-25°C (68-77°F)
- do not refrigerate
- 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, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
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
Call 1-888-594-0828 weekdays 9 AM to 5 PM EST
Principal Display Panel - Kit Carton
COLD & COUGH
NEW FORMULAS
CHILDREN'S
Dimetapp
®
Cold &
Cough
BROMPHENIRAMINE MALEATE (Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)
Relieves + comforts:
- Runny nose
- Itchy, watery eyes
- Sneezing
- Cough
- Runny nose
- Itchy, watery eyes
- Sneezing
- Cough
6+
YRS
Grape Flavor
Alcohol Free
1 BOTTLE
4 FL OZ (118 mL)
8 FL OZ (236 mL) TOTAL
NIGHTTIME
Nighttime
Cold &
Cough
DIPHENHYDRAMINE HCl (Antihistamine/
Cough Suppressant)
Relieves + comforts:
PHARMACIST
RECOMMENDED
6+
YRS
Grape Flavor
Alcohol Free
1 BOTTLE
4 FL OZ (118 mL)
Dimetapp 8oz Carton (Value 01)
* Please review the disclaimer below.
