FDA Label for Brantussin Dm
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- USES
- PURPOSES
- WARNINGS
- DO NOT USE THIS PRODUCT
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK A DOCTOR IF
- KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN
- WHEN USING THIS PRODUCT
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- IF PREGNANT OR BREASTFEEDING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS? COMMENTS?
- PACKAGE LABEL
Brantussin Dm Product Label
The following document was submitted to the FDA by the labeler of this product Brandywine Pharmaceuticals, Llc. 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 Ingredient
Dexbrompheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 15 mg
Phenylephrine Hydrochloride 7.5 mg
Uses
temporarily relieves these symptoms due to the common cold, hayfever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- cough due to minor throat and
- bronchial irritation
- nasal congestion
- reduces swelling of nasal passages
Purposes
Antihistamine
Cough Suppressant
Nasal Decongestant
Warnings
Do not exceed recommended dosage.
Do Not Use This Product
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, 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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes mellitus
Stop Use And Ask A Doctor If
nervousness, dizziness, or sleeplessness occur
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
new symptoms occur
Keep This And All Drugs Out Of The Reach Of Children
In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
When Using This Product
excitability may occur, especially in children
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase the drowsiness effect
be careful when driving a motor vehicle or operating machinery
Ask A Doctor Or Pharmacist Before Use
if you are taking sedatives or tranquilizers.
If Pregnant Or Breastfeeding
ask a health professional before use.
Directions
Do not exceed recommended dosage
Adults and children 12 years of age and over | 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 |
Children 6 to under 12 years of age | 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours |
Children under 6 years of age | Consult a doctor. |
Other Information
Store at 59° - 86°F (15° - 30°C)
Inactive Ingredients
Anhydrous Citric Acid, Glycerin, Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol Solution.
Questions? Comments?
Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041 Mon. - Fri. (8 a.m. to 5 p.m. CST).
Package Label
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