Miclara Lq

Miclara Lq
SPL v3
SPL
SPL Set ID b1e0f143-e192-4bab-9163-ae21c765b765
Route
ORAL
Published
Effective Date 2020-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triprolidine (1.25 mg)
Inactive Ingredients
Citric Acid Monohydrate Methylparaben Ammonium Glycyrrhizate Potassium Citrate Propylene Glycol Propylparaben Water Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-05-15

Description

Miclara LQ- t riprolidine   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. ----------

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Miclara LQ- t riprolidine   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. ----------

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
Section 42229-5

Miclara LQ- t riprolidine  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.

----------

Miclara

Drug Facts

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

 

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)

Active Ingredients

(in each 5 mL teaspoonful) Triprolidine HCl 1.25 mg

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)

Ask A Doctor Before Use

if you are taking sedatives or tranquilizers.

Principal Display Panel

NDC 70868 - 7 3 0 -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

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.


Structured Label Content

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
Section 42229-5 (42229-5)

Miclara LQ- t riprolidine  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.

----------

Miclara (MICLARA)

Drug Facts

Purpose

Antihistamine

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

 

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 (Other information)

Store at 59° - 86°F (15° - 30°C)

Active Ingredients (Active ingredients)

(in each 5 mL teaspoonful) Triprolidine HCl 1.25 mg

Inactive Ingredients (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)

Ask A Doctor Before Use (Ask a doctor before use)

if you are taking sedatives or tranquilizers.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 70868 - 7 3 0 -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

When Using This Product (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 (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. (Keep out of the reach of children.)

In case of accidental overdose seek professional help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)