SUNMARK® CHILDREN'S LORATADINE SRP SF GRAPE

SUNMARK® CHILDREN'S LORATADINE SRP SF GRAPE

Drug Labeling and Warnings

Drug Details

k">

SUNMARK CHILDRENS LORATADINE SRP SF GRAPE- loratadine solution 
McKesson

----------

SUNMARK® CHILDREN'S LORATADINE SRP SF GRAPE

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

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. (1-800-222-1222)

Directions

  • use only with enclosed dosing cup
adults and children 6 years and over2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

  • do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
  • see bottom panel for lot number and expiration date
  • store between 20° and 25°C (68° and 77°F)

Inactive ingredients

butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.

Questions?

Call 1-866-923-4914

Distributed by McKesson
One Post Street, San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

sunmark®

Original
Prescription
Strength

COMPARE TO
CHILDREN'S CLARITIN®
ACTIVE INGREDIENT*

NDC: 70677-0029-1

children's
Allergy
Loratadine Oral Solution
USP, 5 mg/5 mL
(Antihistamine) ALLERGY

Non-Drowsy

24 Hour Relief of:
Sneezing, Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor Allergies
Ages 2 years and older

Dye Free

Dosage Cup Enclosed

SUGAR FREE
GRAPE FLAVOR

4 FL OZ (120 mL)

When taken as directed. See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
SUNMARK CHILDRENS LORATADINE SRP SF GRAPE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70677-0029
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
butylated hydroxyanisole (UNII: REK4960K2U)  
glycerin (UNII: PDC6A3C0OX)  
sorbitol (UNII: 506T60A25R)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
phosphoric acid (UNII: E4GA8884NN)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)  
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPE (sugar free) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70677-0029-11 in 1 CARTON03/17/2017
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680503/17/2017
Labeler - McKesson (177667227)

Revised: 4/2017
 
McKesson


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.