FDA Label for Miclara Dm
View Indications, Usage & Precautions
Miclara Dm Product Label
The following document was submitted to the FDA by the labeler of this product Key Therapeutics. 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)
Dextromethorphan HBr 20mg
Phenylephrine HCl 10mg
Triprolidine HCl 2.5 mg
Uses
temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- cough due to minor throat or bronchial irritation
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- 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 giving 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
- heart disease
- high blood pressure
- a cough that occurs with too much phlegm (mucus)
- a persistent chronic cough such occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Before Use
if you are taking sedatives or tranquilizers.
When Using This Product
- excitability may occur, especially in children
- may cause drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- new symptoms occur
- nervousness, dizziness, or sleeplessness occur
- Cough or nasal congestion lasts 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 accidental overdose seek professional help or contact a Poison Control Center immediately.
Directions
Do not exceed recommended dosage.
| Age | Dose |
| Adults and children 12 years of age and older: | 1 teaspoonful (5mL) every 4 hours, not to exceed 4 teaspoonfuls (20mL) in a 24-hour period or as directed by a doctor |
| Children 6 to under 12 years of age: | ½ teaspoonful (2.5mL) every 4 hours, not to exceed 2 teaspoonfuls (10mL) in a 24-hour period or as directed by a doctor |
| Children under 6 years of age: | Consult a doctor |
Other Information
Store at 59° - 86°F (15° - 30°C)
Inactive Ingredients
Bubble gum flavor, citric acid, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose.
Questions? Comments?
Serious side effects associated with use of this product may be reported to this number. Call 1-888-981-8337 Mon - Fri (8 a.m. to 5 p.m. CST)
Principal Display Panel
NDC 70868-740-16
MICLARA DM
Bubble gum flavor
16 fl oz (473 mL)
* Please review the disclaimer below.