FDA Label for Cold And Cough Dm
View Indications, Usage & Precautions
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Cold And Cough Dm Product Label
The following document was submitted to the FDA by the labeler of this product Publix Super Markets Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 10 Ml)
Brompheniramine maleate, USP 2 mg
Dextromethorphan HBr, USP 10 mg
Phenylephrine HCl, USP 5 mg
Purposes
Antihistamine
Cough suppressant
Nasal decongestant
Uses
• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies• temporarily relieves these symptoms due to hay fever (allergic rhinitis):• sneezing• itching of the nose or throat• runny nose• itchy, watery eyes• temporarily restores freer breathing through the nose
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
• a breathing problem such as emphysema or chronic bronchitis• glaucoma• thyroid disease• high blood pressure• heart disease• diabetes• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema• cough that occurs with too much phlegm (mucus)• trouble urinating due to an enlarged prostate gland
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• alcohol, sedatives and tranquilizers may increase drowsiness• avoid alcoholic beverages• be careful when driving a motor vehicle or operating machinery• excitability may occur, especially in children
Stop Use And Ask A Doctor If
• you get nervous, dizzy or sleepless• symptoms do not get better within 7 days or are accompanied by fever• cough lasts for more than 7 days, comes back, or occurs with 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 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 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
Principal Display Panel
FOR AGES 6 AND UP
CHILDREN’S
cold & cough DM
ANTIHISTAMINE (BROMPHENIRAMINE MALEATE)
COUGH SUPPRESSANT (DEXTROMETHORPHAN HBr)
NASAL DECONGESTANT (PHENYLEPHRINE HCl)
Relieves nasal Symptoms:
runny nose
sneezing
Plus Other Symptoms
itchy, watery eyes
cough
ALCOHOL-FREE
GRAPE FLAVOR
Compare to Active Ingredients in Children’s Dimetapp® Cold & Cough
4 FL OZ (118 mL)
* Please review the disclaimer below.