FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF - diphenhydramine hcl liquid 
Strategic Sourcing Services LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Foster and thrive childrens Allergy Relief 549

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:

WARNINGS

.

DO NOT USE

ASK A DOCTOR BEFORE USE IF THE CHILD HAS

ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS

taking sedatives or tranquilizers

WHEN USING THIS PRODUCT

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

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

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:

2+ Ages

CHERRY FLAVOR

DOSING CUP INCLUDED

8FL OZ(236 mL)

 

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549ft8carton



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:

2+Ages

CHERRY FLAVOR

DOSING CUP INCLUDED

4FL OZ(118 mL)

 

549ft4label
549ft4carton

     

FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-1012-11 in 1 CARTON04/12/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70677-1012-21 in 1 CARTON04/12/2023
2236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/12/2023
Labeler - Strategic Sourcing Services LLC (116956644)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(70677-1012)

Revised: 4/2023
Document Id: 7eaba464-5cdb-4bd4-b272-38fa108658d5
Set id: 7eaba464-5cdb-4bd4-b272-38fa108658d5
Version: 1
Effective Time: 20230412
 
Strategic Sourcing Services LLC