FOSTER AND THRIVE ALLERGY AND CONGESTION D

Manufacturer
Strategic Sourcing Services LLC
Effective date
2026-02-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:46:30

Label at a glance#

ProductFOSTER AND THRIVE ALLERGY AND CONGESTION D
Active ingredientFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through...

Dosage and administration

• do not divide, crush, chew or dissolve the tablet; swallow tablet whole   adults and children 12 years of age and over   take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours   children under 12 years of age   do not use   adults 65 years of age and older   ask a doctor   consumers with kidney disease   ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl 60 mg

Pseudoephedrine HCl 120 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • if you have ever had an allergic reaction to this product or any of its ingredients
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have difficulty swallowing

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • thyroid disease
  • glaucoma
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

  • do not take more than directed
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)
  • the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction to this product occurs. Seek medical help right away.
  • symptoms do not improve within 7 days or are accompanied by a fever
  • you get nervous, dizzy, or sleepless

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

  • do not divide, crush, chew or dissolve the tablet; swallow tablet whole
  • adults and children 12 years of age and over
  • take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
  • children under 12 years of age
  • do not use
  • adults 65 years of age and older
  • ask a doctor
  • consumers with kidney disease
  • ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 21 mg
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 20° and 25°C (68° and 77°F)
  • meets USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-833-358-6431

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENTS IN ALLEGRA-D® 12 HOUR ALLERGY & CONGESTION

Foster & Thrive®

Allergy & Congestion-D

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets

60 mg/120 mg

ANTIHISTAMINE/NASAL DECONGESTANT

12 HR

Non-Drowsy

INDOOR/OUTDOOR RELIEF OF

• Nasal and Sinus Congestion Due to Colds or Allergies

• Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies

ACTUAL SIZE

30 EXTENDED RELEASE TABLETS

foster&thrive-allergy-&-congestion-d-carton-image.jpg
foster&thrive-allergy-&-congestion-d-carton-image.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997406fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN2
99740612 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD2
997406fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FEXOFENADINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1315-1FOSTER AND THRIVE ALLERGY AND CONGESTION D20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE202
70677-1315-1FOSTER AND THRIVE ALLERGY AND CONGESTION D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE12
70677-1315-2FOSTER AND THRIVE ALLERGY AND CONGESTION D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE12
70677-1315-2FOSTER AND THRIVE ALLERGY AND CONGESTION D30 in 1 CARTONTABLET, FILM COATED, EXTENDED RE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1315-1EA - Each70677-1315107c8e0c-8ffc-4fec-a843-4273e79d6ab412026-05-22
70677-1315-2EA - Each70677-13152e1a6ecb-3277-41a5-af8d-10b72f01a06412026-05-22

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-131570677-1315-1, 70677-1315-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216792-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2025-10-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A216792-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2025-10-0784e616aacf4f…
2026-08-18 06:07:402026-07A216792-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2025-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216792-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2025-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216792-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2025-10-0731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216792-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2025-10-07a50c72e98297…

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 ALLERGY AND CONGESTION DFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC945fcda4-0dd8-43cf-a5dd-ecea7995330a2026-02-11WarningsExact identifier
ndc (package): 70677-1315-1
ndc (package): 70677-1315-2
ndc (product): 70677-1315
ndc11 (package): 70677131501
ndc11 (package): 70677131502
spl id: 5a743183-8c1e-458f-8a76-cf207553e6cb
spl set id: 945fcda4-0dd8-43cf-a5dd-ecea7995330a

Reported adverse events (FAERS/openFDA)#

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