MICLARA LQ- triprolidine hydrochloride liquid

Miclara LQ by

Drug Labeling and Warnings

Miclara LQ 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- doxylamine succinate, pseudoephedrine hydrochloride 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 LQ LIQUID

Drug Facts

Active ingredients

(in each 5 mL teaspoonful) Triprolidine HCl 1.25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

• runny nose
  
• sneezing
  
• itching of the nose or throat itchy,
  
• watery eyes

Warnings

Do not exceed recommended dosage.

Do not use this product if you have

• a breathing problem such as emphysema or chronic bronchitis
  
• glaucoma
  
• trouble urinating due to an enlarged prostate gland

 

Ask a doctor before use

if you are taking sedatives or tranquilizers.

When using this product

• may cause excitability especially in children
  
• may cause drowsiness
  
• avoid alcoholic drinks
  
• alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• new symptoms occur

      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.

Adults and children

12 years of age and older:

Children 6 to under 12 years of age:

2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed

8 teaspoonfuls (40mL) in 24-hour

period or as directed by a doctor.

1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls (20mL) 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, monoammonium glycyrrhizinate, 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 70868-730-16 Miclara LQ

Antihistamine

Each 5 mL (1 teaspoonful) contains: Triprolidine HCl 1.25 mg………Antihistamine

Bubble Gum Flavor

Dye Free - Sugar Free - Alcohol Free

16 fl oz. (473 mL)

Distributed by:

      Key Therapeutics, LLC

      Flowood, MS 39232

      Iss. 03/20

INGREDIENTS AND APPEARANCE

MICLARA LQ 
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70868-730
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	1.25 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
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: 70868-730-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/15/2020

Labeler - Key Therapeutics (080318791)