dolgencorp llc. children’s allergy drug facts

dolgencorp llc. children’s allergy drug facts
SPL v4
SPL
SPL Set ID 14acf572-e1f0-40f5-82cf-357cb2f3a051
Route
oral
Published
Effective Date 2025-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loratadine (5 mg)
Inactive Ingredients
edetate disodium glycerin maltitol sodium phosphate, monobasic, unspecified form phosphoric acid propylene glycol water sodium benzoate sorbitol sucralose

Identifiers & Packaging

Marketing Status
anda active Since 2019-06-12

Purpose

Antihistamine

Description

Loratadine 5 mg


Medication Information

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
Purpose

Antihistamine

Directions
  • use only with enclosed dosing cup

adults and children 6 years and over

2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours

children 2 to under 6 years of age

1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours

children under 2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other Information
  • do not use if carton is opened, or if printed neckband is broken or missing
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients

edetate disodium, glycerin, maltitol, monobasic sodium phosphate, natural and artificial grape flavor, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Description

Loratadine 5 mg

Principal Display Panel

DG|health

Compare to the active ingredient of Children’s Claritin®

Ages 2 + Years

Children’s Allergy

Loratadine Oral Solution, 5 mg/5mL

Antihistamine

24 Hour Relief of:

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat or nose

24 HOUR

Non-Drowsy*

Dye Free

Indoor & Outdoor Allergies

Grape Flavor

*When taken as directed. See Drug Facts Panel.

4 FL OZ (120 mL)

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients

Questions Or Comments?

1-888-309-9030

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).

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Active Ingredient (in Each 5 Ml Teaspoonful)

Loratadine 5 mg


Structured Label Content

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
Purpose

Antihistamine

Directions
  • use only with enclosed dosing cup

adults and children 6 years and over

2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours

children 2 to under 6 years of age

1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours

children under 2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other Information (Other information)
  • do not use if carton is opened, or if printed neckband is broken or missing
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

edetate disodium, glycerin, maltitol, monobasic sodium phosphate, natural and artificial grape flavor, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Principal Display Panel

DG|health

Compare to the active ingredient of Children’s Claritin®

Ages 2 + Years

Children’s Allergy

Loratadine Oral Solution, 5 mg/5mL

Antihistamine

24 Hour Relief of:

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat or nose

24 HOUR

Non-Drowsy*

Dye Free

Indoor & Outdoor Allergies

Grape Flavor

*When taken as directed. See Drug Facts Panel.

4 FL OZ (120 mL)

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients

Questions Or Comments? (Questions or comments?)

1-888-309-9030

When Using This Product (When using this product)

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.

Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL teaspoonful))

Loratadine 5 mg


Advanced Ingredient Data


Raw Label Data

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