Foster And Thrive Childrens Allergy Relief 549

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

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

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

Warnings

.

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

Do Not Use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Other Information

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

Active Ingredient(s)

Diphenhydramine HCl 12.5 mg

Inactive Ingredients

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

Questions Or Comments

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

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)

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

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

Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

.

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

Do Not Use (DO NOT USE)

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Other Information (OTHER INFORMATION)

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

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Diphenhydramine HCl 12.5 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions Or Comments (QUESTIONS OR COMMENTS)

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

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)

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

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "PURPOSE": "Antihistamine", "WARNINGS": ".", "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", "DO NOT USE": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "OTHER INFORMATION": "each 5 mL contains: sodium 5 mg dosing cup provided store between 20°-25°C(68°-77°F)", "ACTIVE INGREDIENT(S)": "Diphenhydramine HCl 12.5 mg", "INACTIVE INGREDIENTS": "carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water , saccharin sodium, sodium benzoate, sorbitol.", "QUESTIONS OR COMMENTS": "Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST", "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)", "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"}

Foster And Thrive Childrens Allergy Relief 549

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information