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NDC 70868-0730-16 Miclara LQ 1.25 mg/5mL Details

Miclara LQ 1.25 mg/5mL

Miclara LQ is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Key Therapeutics. The primary component is TRIPROLIDINE HYDROCHLORIDE.

Product Information

NDC	70868-0730
Product ID	70868-730_d67cfbdf-9636-4ba6-e053-2a95a90aacbb
Associated GPIs	41100040100910
GCN Sequence Number	011649
GCN Sequence Number Description	triprolidine HCl SYRUP 1.25MG/5ML ORAL
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	46610
HICL Sequence Number	004508
HICL Sequence Number Description	TRIPROLIDINE HCL
Brand/Generic	Brand
Proprietary Name	Miclara LQ
Proprietary Name Suffix	n/a
Non-Proprietary Name	TRIPROLIDINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	1.25
Active Ingredient Units	mg/5mL
Substance Name	TRIPROLIDINE HYDROCHLORIDE
Labeler Name	Key Therapeutics
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70868-0730-16 (70868073016)

Pricing Information	N/A
NDC Package Code	70868-730-16
Billing NDC	70868073016
Package	473 mL in 1 BOTTLE (70868-730-16)
Marketing Start Date	2020-05-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b1e0f143-e192-4bab-9163-ae21c765b765 Details

SPL UNCLASSIFIED SECTION

Miclara LQ- triprolidine 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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70868-730-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020

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

Labeler - Key Therapeutics (080318791)

Name	Address	ID/FEI	Business Operations
Establishment
TG United		172837085	manufacture(70868-730)

Revised: 1/2022

Document Id: d67cfbdf-9636-4ba6-e053-2a95a90aacbb

Set id: b1e0f143-e192-4bab-9163-ae21c765b765

Version: 3

Effective Time: 20220126