foster and thrive childrens allergy relief 549

foster and thrive childrens allergy relief 549
SPL v2
SPL
SPL Set ID 7eaba464-5cdb-4bd4-b272-38fa108658d5
Route
oral
Published
Effective Date 2024-12-13
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (12.5 mg)
Inactive Ingredients
carboxymethylcellulose sodium anhydrous citric acid glycerin saccharin sodium water sodium benzoate sorbitol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-04-12

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg


Medication Information

Warnings

.

Purpose

Antihistamine

Directions
  • find right dose on chart below
  • mL=milliliter
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
AGE(yr)  DOSE(mL)
 children under 2 years  do not use
 children 2 to 5 years  do not use unless directed by a doctor
 children 6 to 11 years  5 mL to 10 mL


Other Information
  • each 5 mL contains: sodium 5 mg
  • dosing cup provided
  • store between 20°-25°C(68°-77°F)
Inactive Ingredients

carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water , saccharin sodium, sodium benzoate, sorbitol.

Description

Diphenhydramine HCl 12.5 mg

Principal Display Panel

NDC 70677-1012-2

COMPARE TO CHILDREN'S BENADRYL® ORAL SOLUTION ACTIVE INGREDIENT*

Foster & Thrive TM

Children's Allergy Relief 

Diphenhydramine HCl oral solution,

12.5 mg/5ml

ANTIHISTAMINE

Dye Free

4-6 Hours/Dose

Relief of:

  • Runny Nose
  • Itchy Watery Eyes
  • Sneezing
  • Itchy Throat or Nose

2+ Ages

CHERRY FLAVOR

DOSING CUP INCLUDED

8FL OZ(236 mL)

NDC 70677-1012-1

COMPARE TO CHILDREN'S BENADRYL® ORAL SOLUTION ACTIVE INGREDIENT*

Foster & Thrive TM

Children's Allergy Relief 

Diphenhydramine HCl oral solution,

12.5 mg/5ml

ANTIHISTAMINE

Dye Free

4-6 Hours/Dose

Relief of:

  • Runny Nose
  • Itchy Watery Eyes
  • Sneezing
  • Itchy Throat or Nose

2+Ages

CHERRY FLAVOR

DOSING CUP INCLUDED

4FL OZ(118 mL)

Use(s)

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
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Active Ingredient(s)

Diphenhydramine HCl 12.5 mg

Questions Or Comments

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

When Using This Product
  • sedatives and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • excitability may occur, especially in 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 the Child Has
  • glaucoma
  • a breathing problem such as chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If the Child Is

taking sedatives or tranquilizers


Structured Label Content

Warnings (WARNINGS)

.

Purpose (PURPOSE)

Antihistamine

Directions (DIRECTIONS)
  • find right dose on chart below
  • mL=milliliter
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
AGE(yr)  DOSE(mL)
 children under 2 years  do not use
 children 2 to 5 years  do not use unless directed by a doctor
 children 6 to 11 years  5 mL to 10 mL


Other Information (OTHER INFORMATION)
  • each 5 mL contains: sodium 5 mg
  • dosing cup provided
  • store between 20°-25°C(68°-77°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water , saccharin sodium, sodium benzoate, sorbitol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 70677-1012-2

COMPARE TO CHILDREN'S BENADRYL® ORAL SOLUTION ACTIVE INGREDIENT*

Foster & Thrive TM

Children's Allergy Relief 

Diphenhydramine HCl oral solution,

12.5 mg/5ml

ANTIHISTAMINE

Dye Free

4-6 Hours/Dose

Relief of:

  • Runny Nose
  • Itchy Watery Eyes
  • Sneezing
  • Itchy Throat or Nose

2+ Ages

CHERRY FLAVOR

DOSING CUP INCLUDED

8FL OZ(236 mL)

NDC 70677-1012-1

COMPARE TO CHILDREN'S BENADRYL® ORAL SOLUTION ACTIVE INGREDIENT*

Foster & Thrive TM

Children's Allergy Relief 

Diphenhydramine HCl oral solution,

12.5 mg/5ml

ANTIHISTAMINE

Dye Free

4-6 Hours/Dose

Relief of:

  • Runny Nose
  • Itchy Watery Eyes
  • Sneezing
  • Itchy Throat or Nose

2+Ages

CHERRY FLAVOR

DOSING CUP INCLUDED

4FL OZ(118 mL)

Use(s) (USE(S))

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
Do Not Use (DO NOT USE)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Diphenhydramine HCl 12.5 mg

Questions Or Comments (QUESTIONS OR COMMENTS)

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

When Using This Product (WHEN USING THIS PRODUCT)
  • sedatives and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • excitability may occur, especially in children
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 the Child Has (ASK A DOCTOR BEFORE USE IF THE CHILD HAS)
  • glaucoma
  • a breathing problem such as chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If the Child Is (ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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