FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF- diphenhydramine hcl liquid

Foster and Thrive Childrens Allergy Relief by

Drug Labeling and Warnings

Foster and Thrive Childrens Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Diphenhydramine HCl 12.5 mg

PURPOSE

Antihistamine

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

.

DO NOT USE

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

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

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).

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.

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)

 

     

INGREDIENTS AND APPEARANCE

FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1012-1	1 in 1 CARTON	04/12/2023
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 70677-1012-2	1 in 1 CARTON	04/12/2023
2		236 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/12/2023

Labeler - Strategic Sourcing Services LLC (116956644)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(70677-1012)