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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Miclara DM

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:

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.

AgeDose
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 PANEL
NDC 70868-740-16
MICLARA DM
Bubble gum flavor
16 fl oz (473 mL)

MICLARA DM 
dextromethorphan hbr, phenylephrine hcl, triprolidine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70868-740
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70868-740-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2020
Labeler - Key Therapeutics (080318791)
Establishment
NameAddressID/FEIBusiness Operations
TG United172837085manufacture(70868-740)

Revised: 1/2022
Document Id: d67cf0cc-7c79-8640-e053-2995a90a7b1e
Set id: c86e012b-17d0-4ffd-b815-9c07771bfaf1
Version: 3
Effective Time: 20220126
 
Key Therapeutics