Active Ingredients (In Each 10 Ml)
Brompheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Childrens Cold And Cough Relief Dm Solution
FDA Label NDC 0363-3611
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Childrens Cold And Cough Relief Dm (NDC 0363-3611). 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 active ingredients (in each 10 ml), purposes, 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
Purposes
Antihistamine
Cough suppressant
Uses
- temporarily relieves:
- cough
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever (or other upper respiratory allergies)
- temporarily alleviates the intensity of coughing
Do Not Use
- 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.
- to make a child sleepy
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 such as emphysema or chronic bronchitis
- cough that lasts or is chronic such as occurs with smoking, asthma, 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 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
cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
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 (1-800-222-1222).
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 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 4 mg
- store at 20°-25°C (68°-77°F)
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Walgreens
WALGREENS PHARMACIST RECOMMENDED
Compare to the active ingredients in Children’s Dimetapp® Cold & Cough
Children’s Cold & Cough Relief DM
BROMPHENIRAMINE MALEATE / ANTIHISTAMINE
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
Alcohol Free
• Relieves: Runny Nose, Itchy, Watery Eyes Coughing, Sneezing
AGES 6 YEARS & OLDER
Grape flavor
4 FL OZ (118 mL)
SEE NEW DRUG FACTS
26k-94-childrens-cold-and-cough-relief-dm.jpg (26k 94 Childrens Cold And Cough Relief Dm 01)
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