DailyMed - FEXOFENADINE HYDROCHLORIDE tablet

NDC Code(s): 55111-782-01, 55111-782-30, 55111-782-78, 55111-782-79, view more
55111-782-90, 55111-783-01, 55111-783-24, 55111-783-28, 55111-783-30, 55111-783-60, 55111-783-78, 55111-783-79, 55111-783-90, 55111-784-01, 55111-784-05, 55111-784-07, 55111-784-15, 55111-784-18, 55111-784-23, 55111-784-28, 55111-784-29, 55111-784-30, 55111-784-35, 55111-784-40, 55111-784-43, 55111-784-45, 55111-784-59, 55111-784-75, 55111-784-78, 55111-784-79, 55111-784-90
Packager: Dr. Reddy's Laboratories Limited

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 26, 2024

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Active ingredient(s)
Fexofenadine HCl USP, 30 mg - Fexofenadine HCl USP, 60 mg - Fexofenadine HCl USP, 180 mg

Fexofenadine HCl USP, 30 mg

Fexofenadine HCl USP, 60 mg

Fexofenadine HCl USP, 180 mg
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Purpose
Antihistamine

Antihistamine
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Use(s)
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
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
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Warnings
Do not use - if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have - kidney disease. Your doctor should determine if you ...
Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

kidney disease. Your doctor should determine if you need a different dose.
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)
Stop use and ask doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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Directions

adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours - children under 12 years of agedo not use - adults ...

Other information
safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing - store between 20° and 25°C (68° and 77°F) protect from excessive moisture - this product ...
- safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
- this product meets the requirements of USP Dissolution Test 4
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Inactive ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium ...

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide
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Questions?
Call 1-888-375-3784

Call 1-888-375-3784

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PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION
Bottle label:

Bottle label:

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PRINCIPAL DISPLAY PANEL
Fexofenadine HCl Tablets, 30 mg Carton:

Fexofenadine HCl Tablets, 30 mg Carton:

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PRINCIPAL DISPLAY PANEL
Fexofenadine HCl Tablets USP, 60 mg Carton:

Fexofenadine HCl Tablets USP, 60 mg Carton:

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PRINCIPAL DISPLAY PANEL
Fexofenadine HCl Tablets USP, 180 mg Carton Label:

Fexofenadine HCl Tablets USP, 180 mg Carton Label:

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INGREDIENTS AND APPEARANCE

Product Information

FEXOFENADINE HYDROCHLORIDE fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55111-782
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	Fexofenadine Hydrochloride	30 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
magnesium stearate (UNII: 70097M6I30)
mannitol (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
polyethylene glycol 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	4mm
Flavor		Imprint Code	192;R
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55111-782-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
2	NDC:55111-782-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
3	NDC:55111-782-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
4	NDC:55111-782-78	10 in 1 CARTON	01/03/2011
4	NDC:55111-782-79	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076502	01/03/2011

FEXOFENADINE HYDROCHLORIDE fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55111-783
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	Fexofenadine Hydrochloride	60 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
magnesium stearate (UNII: 70097M6I30)
mannitol (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
polyethylene glycol 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	5mm
Flavor		Imprint Code	193;R
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55111-783-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
2	NDC:55111-783-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
3	NDC:55111-783-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
4	NDC:55111-783-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
5	NDC:55111-783-78	10 in 1 CARTON	01/03/2011
5	NDC:55111-783-79	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:55111-783-28	2 in 1 CARTON	12/01/2020
6		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC:55111-783-24	4 in 1 CARTON	12/01/2020
7		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076502	01/03/2011

FEXOFENADINE HYDROCHLORIDE fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55111-784
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	Fexofenadine Hydrochloride	180 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	7mm
Flavor		Imprint Code	194;R
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55111-784-30	1 in 1 CARTON	01/03/2011
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:55111-784-43	2 in 1 CARTON	01/03/2011
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:55111-784-40	1 in 1 CARTON	01/03/2011
3		40 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:55111-784-45	1 in 1 CARTON	01/03/2011
4		45 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:55111-784-59	2 in 1 CARTON	01/03/2011
5		60 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:55111-784-75	1 in 1 CARTON	01/03/2011
6		70 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:55111-784-90	1 in 1 CARTON	01/03/2011
7		90 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:55111-784-01	1 in 1 CARTON	01/03/2011
8		100 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC:55111-784-15	1 in 1 CARTON	01/03/2011
9		150 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC:55111-784-18	1 in 1 CARTON	01/03/2011
10		180 in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC:55111-784-05	1 in 1 CARTON	01/03/2011
11		500 in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC:55111-784-23	1 in 1 CARTON	01/03/2011
12		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
13	NDC:55111-784-07	1 in 1 CARTON	01/03/2011
13		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
14	NDC:55111-784-35	2 in 1 CARTON	12/01/2021
14		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
15	NDC:55111-784-29	3 in 1 CARTON	01/03/2011
15		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
16	NDC:55111-784-78	10 in 1 CARTON	01/03/2011
16	NDC:55111-784-79	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
17	NDC:55111-784-28	3 in 1 CARTON	01/03/2011
17		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076502	01/03/2011

Labeler - Dr. Reddy's Laboratories Limited (650562841)

Name	Address	ID/FEI	Business Operations
Establishment
Dr. Reddy's Laboratories Limited (FTO III)		918608162	analysis(55111-784, 55111-782, 55111-783) , manufacture(55111-784, 55111-782, 55111-783)

Name	Address	ID/FEI	Business Operations
Establishment
Reed-Lane, Inc.		001819879	pack(55111-782, 55111-783, 55111-784)

Name	Address	ID/FEI	Business Operations
Establishment
Dr. Reddy's Laboratories Louisiana, LLC		830397282	pack(55111-784)

Name	Address	ID/FEI	Business Operations
Establishment
DR. REDDY'S LABORATORIES LIMITED		860037244	analysis(55111-783) , manufacture(55111-783) , pack(55111-783, 55111-784)

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Published Date (What is this?)	Version	Files
Jul 29, 2024	18 (current)	download
Dec 23, 2022	17	download
Oct 28, 2021	16	download
Jun 29, 2021	15	download
Sep 4, 2020	14	download
Nov 22, 2019	12	download
Nov 14, 2019	11	download
Aug 10, 2018	10	download
Aug 20, 2013	7	download
Jul 12, 2011	4	download

	RxCUI	RxNorm NAME	RxTTY
1	997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN
2	997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD
3	997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY
4	997488	fexofenadine HCl 30 MG Oral Tablet	PSN
5	997488	fexofenadine hydrochloride 30 MG Oral Tablet	SCD
6	997501	fexofenadine HCl 60 MG Oral Tablet	PSN
7	997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD

Label: FEXOFENADINE HYDROCHLORIDE tablet

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

adults and children 12 years of age and over	take one 180 mg tablet with water once a day; do not take more than 1 tablet 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

	NDC
1	55111-782-01
2	55111-782-30
3	55111-782-78
4	55111-782-79
5	55111-782-90
6	55111-783-01
7	55111-783-24
8	55111-783-28
9	55111-783-30
10	55111-783-60
11	55111-783-78
12	55111-783-79
13	55111-783-90
14	55111-784-01
15	55111-784-05
16	55111-784-07
17	55111-784-15
18	55111-784-18
19	55111-784-23
20	55111-784-28
21	55111-784-29
22	55111-784-30
23	55111-784-35
24	55111-784-40
25	55111-784-43
26	55111-784-45
27	55111-784-59
28	55111-784-75
29	55111-784-78
30	55111-784-79
31	55111-784-90

Label: FEXOFENADINE HYDROCHLORIDE tablet

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

FEXOFENADINE HYDROCHLORIDE tablet

Number of versions: 10

FEXOFENADINE HYDROCHLORIDE tablet

FEXOFENADINE HYDROCHLORIDE tablet

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FEXOFENADINE HYDROCHLORIDE tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.