Active Ingredients
(in each 5 mL teaspoonful)
Dextromethorphan HBr 20mg
Phenylephrine HCl 10mg
Triprolidine HCl 2.5 mg
Miclara Dm
FDA Label NDC 70868-740
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Key Therapeutics for the product Miclara Dm (NDC 70868-740). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, uses, warnings, do not use this product, ask a doctor before use if you have, ask a doctor before use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
Pricipal Display Panelndc 70868-740-16miclara Dmbubble Gum Flavor16 Fl Oz (473 mL) (Miclara Dm 01)
* Please review the disclaimer below.
