MICLARA DM- dextromethorphan hbr, phenylephrine hcl, triprolidine hcl liquid

Miclara DM by

Drug Labeling and Warnings

Miclara DM by is a Otc medication manufactured, distributed, or labeled by Key Therapeutics, TG United. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

MICLARA LQ LIQUID

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Dextromethorphan HBr       20mg

Phenylephrine HCl             10mg

Triprolidine HCl             2.5 mg

Purpose

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)

INGREDIENTS AND APPEARANCE

MICLARA DM 
dextromethorphan hbr, phenylephrine hcl, triprolidine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70868-740
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70868-740-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/01/2020

Labeler - Key Therapeutics (080318791)

Establishment
Name	Address	ID/FEI	Business Operations
TG United		172837085	manufacture(70868-740)