FDA Label for Endacof Dm
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- 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 THE REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
Endacof Dm Product Label
The following document was submitted to the FDA by the labeler of this product Larken Laboratories, 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)
Brompheniramine Maleate, USP 1 mg
Dextromethorphan HBr, USP 5 mg
Phenylephrine HCl, USP 2.5 mg
Purpose
Brompheniramine Maleate Antihistamine
Dextromethorphan HBr Antitussive (cough suppressant)
Phenylephrine HCl Nasal decongestant
Uses
Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- cough due to minor throat and bronchial irritation
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily restores freer breathing through the nose
Warnings
Do not use
- to sedate a child or 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 drug.
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
- taking any other nasal decongestant or stimulant
- taking sedatives or tranquilizers
When Using This Product
Do not exceed recommended dosage.
- marked drowsiness may occur
- 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
- 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. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of The Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center immediately.
Directions
Do not exceed 6 doses in a 24-hour period
| Age | Dose |
| Adults and children over 12 years of age: | 4 teaspoonsful (20 mL) every 4 hours |
| Children 6 to under 12 years of age: | 2 teaspoonsful (10 mL) every 4 hours |
| Children under 6 years of age: | Ask your doctor |
Other Information
- store at 20°-25°C (68°-77°F)
- very low sodium, contains 1 mg sodium per teaspoonful (5 mL)
Inactive Ingredients
Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water saccharin sodium, sorbitol solution and strawberry flavoring
Questions Or Comments
Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.
Principal Display Panel
Figure 1: 16 oz. Bottle Label
* Please review the disclaimer below.