Active Ingredients And Purpose
Active ingredient(s)
Fexofenadine HCl USP, 60 mg Pseudoephedrine HCl USP, 120 mg
Purpose
Antihistamine Nasal decongestant
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Manufacturer
- Rite Aid Corporation
- Effective date
- 2025-12-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:22:37
Key Label Information#
Uses
Use(s)
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 relives 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
Directions And Dosage
Directions
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 Label Information
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, ferric oxide (iron oxide yellow), HPMC 2910 / hypromellose (6 Cps), hydroxypropyl cellulose, hypromellose (methocel K100M DC2), macrogol (polyethylene glycol MW 400), macrogol (polyethylene glycol MW 8000), magnesium stearate, microcrystalline cellulose (avicel PH 101), microcrystalline cellulose (avicel PH102), pregelatinized starch.
Questions?
Call 1-888-375-3784
Principal Display Panel
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 997406 | fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet | PSN | 5 |
| 997406 | 12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet | SCD | 5 |
| 997406 | fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet | SY | 5 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| FEXOFENADINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-0021-4 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 5 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 5 | 5 | |
| 11822-0021-4 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 4 in 1 CARTON | TABLET, EXTENDED RELEASE | 4 | 5 | |
| 11822-0021-6 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 5 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 5 | 5 | |
| 11822-0021-6 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 6 in 1 CARTON | TABLET, EXTENDED RELEASE | 6 | 5 |
Products#
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- FEXOFENADINE
- PSEUDOEPHEDRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11822-0021 | 11822-0021-6, 11822-0021-4 |
Ingredients#
Complete SPL Sections#
Active ingredient(s)
Fexofenadine HCl USP, 60 mg Pseudoephedrine HCl USP, 120 mg
Purpose
Antihistamine Nasal decongestant
Use(s)
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 relives 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
Directions
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
safety sealed: do not use if carton is opened or if individual blister units are torn or opened store between 20° to 25°C (68° to 77°F) store between 20° to 25°C (68° to 77°F) FDA approved dissolution test specifications differ from USP. FDA approved organic impurities test procedure differs from USP Procedure 1.
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, ferric oxide (iron oxide yellow), HPMC 2910 / hypromellose (6 Cps), hydroxypropyl cellulose, hypromellose (methocel K100M DC2), macrogol (polyethylene glycol MW 400), macrogol (polyethylene glycol MW 8000), magnesium stearate, microcrystalline cellulose (avicel PH 101), microcrystalline cellulose (avicel PH102), pregelatinized starch.
Questions?
Call 1-888-375-3784