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NDC 51316-0007-84 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60; 120 mg/1; mg/1 Details
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60; 120 mg/1; mg/1
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy, Inc.. The primary component is FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE.
Product Information
NDC | 51316-0007 |
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Product ID | 51316-007_46975e97-aa0a-4ae8-88e5-13d6fe3443de |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Route | ORAL |
Active Ingredient Strength | 60; 120 |
Active Ingredient Units | mg/1; mg/1 |
Substance Name | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
Labeler Name | CVS Pharmacy, Inc. |
Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA209116 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 51316-0007-84 (51316000784)
NDC Package Code | 51316-007-84 |
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Billing NDC | 51316000784 |
Package | 3 BLISTER PACK in 1 CARTON (51316-007-84) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
Marketing Start Date | 2022-11-17 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e9161bb2-190f-14b3-e053-2995a90a9b2f Details
Drug Facts
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 the nose
Warnings
Do not use
- 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
When using this product
- 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
Keep out of reach of children.
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 at 20-25°C (68-77°F).
- Meets USP dissolution test 7
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid
Questions or Comments?
call 1-855-274-4122
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2023 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in India
Code: TS/DRUGS/22/2009
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton
CVSHealth®
Compare to the active ingredients in Allegra-D®
12 Hour Allergy & Congestion Tablets*
NDC 51316-007-67
Original Prescription Strength
ALLERGY & CONGESTION RELIRF
Allergy Relief D
Fexofenadine HCl 60 mg/ Antihistamine
PSEUDOEPHEDRINE HCI 120 mg / Nasal decongestant
EXTENDED-RELEASE TABLETS, USP
12
HOUR
INDOOR/OUTDOOR RELIEF OF:
• Nasal & sinus congestion due to
colds or allergies
• Sneezing; Runny nose; Itchy, watery eyes
& Itchy nose or throat due to allergies
Non-drowsy
20 EXTENDED-RELEASE TABLETS
INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release |
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Labeler - CVS Pharmacy, Inc. (062312574) |
Registrant - Aurohealth LLC (078728447) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Aurobindo Pharma Limited | 650381903 | ANALYSIS(51316-007) , MANUFACTURE(51316-007) |