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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 |
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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)
NDC Package Code | 70868-730-16 |
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Billing NDC | 70868073016 |
Package | 473 mL in 1 BOTTLE (70868-730-16) |
Marketing Start Date | 2020-05-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b1e0f143-e192-4bab-9163-ae21c765b765 Details
SPL UNCLASSIFIED SECTION
Uses
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
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
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
Inactive ingredients
Questions? Comments?
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
MICLARA LQ
triprolidine hydrochloride liquid |
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Labeler - Key Therapeutics (080318791) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
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