CHILDRENS PEDIACLEAR ALLERGY- triprolidine hydrochloride liquid

Childrens PediaClear Allergy by

Drug Labeling and Warnings

Childrens PediaClear Allergy by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Children’s PediaClear Allergy

NDC: 58809-740-50

Antihistamine

50 mL

Active ingredients (in each 1 mL)

Triprolidine HCl  0.313 mg

Purpose

Antihistamine

Uses

• temporarily relieves:
  
• runny nose
  
• sneezing
  
• itching of nose and throat
  
• itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis

Warnings

•  May cause excitability, especially in children

Ask a doctor before use if your child has

• glaucoma
  
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor before use

if the child is taking sedatives or tranquilizers

When using this product

•  do not use more than directed
  
• may cause marked drowsiness
  
• sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if: 

• new symptoms occur
  

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

•  take every 6 hours
  
•  do not take more than 4 doses in 24 hours or as directed by a doctor
  
•  do not give more than directed or exceed the recommended daily dosage
  
• Children 6 to under 12 years of age: 4 mL (4 dropperfuls)
  
• Children under 6 years of age: ask a doctor
  

Other Information

• store at controlled room temperature 15°-30°C (59°-86°F)
  
• Tamper Evident: Do not use if seal is broken or missing.
  

Inactive ingredients

Citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol ,sucralose

Questions?

Call 1-888-535-0305 9 a.m. -5 p.m. CST

Distributed by:

GM Pharmaceuticals, Inc.

Arlington, TX 76015

mper evident by foil seal under cap. Do not use if

Professional Labeling

Use Only as Directed by a Doctor

• Children 4 months to under 2 years of age: 1 mL (1 dropperful)
  
• Children 2 to under 4 years of age: 2 mL (2 dropperfuls)
  
• Children 4 to under 6 years of age: 3 mL (3 dropperfuls)

• Take every 6 hours.
  
• Do not exceed 4 doses in 24 hours.

PRINCIPAL DISPLAY PANEL

NDC: 58809-740-50
Children’s
PediaClear
Allergy
1.69 fl. oz. (50 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS PEDIACLEAR ALLERGY 
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-740
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	0.313 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-740-50	50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	06/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/25/2019

Labeler - GM Pharmaceuticals, INC (793000860)