Miclara Lq Liquid
Drug Facts
Miclara Lq
FDA Label NDC 70868-730
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Key Therapeutics for the product Miclara Lq (NDC 70868-730). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding miclara lq liquid, active ingredients, purpose, uses, warnings, ask a doctor before use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Principal Display Panelndc 70868-730-16 Miclara Lqantihistamine Each 5 mL (1 Teaspoonful) Contains: Triprolidine HCl 1.25 mg………antihistaminebubble Gum Flavordye Free (Sugar Free)
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