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

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. ----------


Medication Information

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

 

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
Purpose

Antihistamine

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.

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. ----------

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

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

Active Ingredients

(in each 5 mL teaspoonful) Triprolidine HCl 1.25 mg

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.

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

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

 

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
Purpose

Antihistamine

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)

Inactive Ingredients (Inactive ingredients)

Bubble gum flavor, citric acid, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose.

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

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

Active Ingredients (Active ingredients)

(in each 5 mL teaspoonful) Triprolidine HCl 1.25 mg

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.

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

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