FDA Label for Dexbrompheniramine-dm-phenylephrine 2-15-7.5
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- 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
- QUESTIONS? COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Dexbrompheniramine-dm-phenylephrine 2-15-7.5 Product Label
The following document was submitted to the FDA by the labeler of this product Addgen Pharmaceuticals, 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 5 mL teaspoonful)
Dexbrompheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 15 mg
Phenylephrine Hydrochloride 7.5mg
Purpose
Antihistamine
Antitussive
Nasal Decongestant
Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of nose or throat
- itchy, watery eyes
- cough due to minor throat and bronchial irritation
- nasal congestion
- reduces swelling of nasal passages
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 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
- 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
Ask A Doctor Or Pharmacist Before Use
if you are
taking sedatives or tranquilizers.
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
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
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.
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 a 24 hours |
| 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.Principal Display Panel
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