FDA.reportPublic FDA data

Foster and Thrive Childrens Allergy Relief

Manufacturer
Strategic Sourcing Services LLC | Guardian Drug Company
Effective date
2024-12-13
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:20

Label at a glance#

ProductFoster and Thrive Childrens Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE(S)

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

.

DO NOT USE

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as chronic bronchitis

ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • sedatives and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • excitability may occur, especially in children

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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 SAFETY INFORMATION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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)

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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)

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN2
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD2
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1012-1Foster and Thrive Childrens Allergy Relief118 mL in 1 BOTTLELIQUID1182
70677-1012-1Foster and Thrive Childrens Allergy Relief1 in 1 CARTONLIQUID12
70677-1012-2Foster and Thrive Childrens Allergy Relief236 mL in 1 BOTTLELIQUID2362
70677-1012-2Foster and Thrive Childrens Allergy Relief1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1012FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 4 package rows20241215_7eaba464-5cdb-4bd4-b272-38fa108658d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1012-1ML - Milliliter70677-1012fe420a73-e4db-487d-acf4-a017a71657e812023-08-08
70677-1012-2ML - Milliliter70677-10126dc81fa1-0027-4af2-b9b3-528eaf01c98712023-08-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-101270677-1012-1, 70677-1012-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foster and Thrive Childrens Allergy ReliefDIPHENHYDRAMINE HCLStrategic Sourcing Services LLC7eaba464-5cdb-4bd4-b272-38fa108658d52024-12-13WarningsExact identifier
ndc (package): 70677-1012-1
ndc (package): 70677-1012-2
ndc (product): 70677-1012
ndc11 (package): 70677101202
ndc11 (package): 70677101201
spl id: 9a6180bd-d63f-4b21-b18e-2876ec46c334
spl set id: 7eaba464-5cdb-4bd4-b272-38fa108658d5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.