DailyMed - FEXOFENADINE HCL tablet, film coated

NDC Code(s): 69230-201-01, 69230-201-05, 69230-202-01, 69230-202-05, view more
69230-202-11, 69230-202-30, 69230-202-45, 69230-202-60, 69230-202-90
Packager: Camber Consumer Care

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

Drug Label Information

Updated November 6, 2023

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ALLERGY Active ingredient (in each film-coated tablet)
Fexofenadine HCl USP, 60mg and 180 mg

Fexofenadine HCl USP, 60mg and 180 mg

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Purpose
Antihistamine

Antihistamine
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Uses
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 a 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 (1800-222-1222).

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Directions

FOR 60mg - adults and children 12 years of age and overtake two 60mg tablets with water evrery 12 hours; do not take more than 2 tablets in 24 hours - children under 12 years of agedo not ...

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 - each tablet ...
- 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
- each tablet contains: sodium 8.2 mg (for 180mg)
- each tablet contains: sodium 2.7 mg (for 60mg)
- this product meets the requirements of USP Dissolution Test 2
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Inactive ingredients
anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch (maize), stearic acid, opadry pink 03B84893 containing hypromellose ...

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch (maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide.
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Questions or comments?
Call 1-888-588-1418 - Distributed by: Camber Consumer Care, Inc. Piscataway, NJ 08854, USA, Made in USA

Call 1-888-588-1418

Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA,

Made in USA
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Camber Consumer Care - Compare to the active ingredient in Allegra® Allergy 24 Hour Tablets Allergy Relief - 24 HOUR FEXOFENADINE HYDROCHLORIDE TABLETS USP, 180 mg Antihistamine Indoor & Outdoor Allergies

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CAMBER CONSUMER CARE
NDC 69230-201-01 Compare to the active ingredient in Allegra® Allergy* Non-Drowsy - Fexofenadine Hydrochloride Tablets USP - 60 mg - Antihistamine - 12 HR Indoor/Outdoor Allergy ...
NDC 69230-201-01 Compare to the active ingredient in Allegra® Allergy*

Non-Drowsy

Fexofenadine Hydrochloride Tablets USP

60 mg

Antihistamine

12 HR Indoor/Outdoor Allergy Relief

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

NDC 69230-201-05 Compare to the active ingredient in Allegra® Allergy*

Non-Drowsy

Fexofenadine Hydrochloride Tablets USP

60 mg

Antihistamine

12 HR Indoor/Outdoor Allergy Relief
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
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FOR 180mg
adults and children 12 years of age and over	take one 180mg 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

INGREDIENTS AND APPEARANCE

Product Information

FEXOFENADINE HCL fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69230-202
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	SG;202
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69230-202-30	1 in 1 CARTON	09/16/2015
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:69230-202-45	1 in 1 CARTON	09/16/2015
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:69230-202-60	1 in 1 CARTON	09/16/2015
3		60 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:69230-202-90	1 in 1 CARTON	09/16/2015
4		90 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:69230-202-01	1 in 1 CARTON	09/16/2015
5		100 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:69230-202-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/16/2015
7	NDC:69230-202-11	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/16/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204507	09/16/2015

FEXOFENADINE HCL fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69230-201
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL (Modified Oval)	Size	12mm
Flavor		Imprint Code	SG;201
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69230-201-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/08/2021
2	NDC:69230-201-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/08/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204507	12/08/2021

Labeler - Camber Consumer Care (079539968)

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Published Date (What is this?)	Version	Files
Nov 8, 2023	3 (current)	download
Dec 14, 2021	2	download
Jan 19, 2016	1	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	997501	fexofenadine HCl 60 MG Oral Tablet	PSN
5	997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD

Label: FEXOFENADINE HCL tablet, film coated

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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 a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

FOR 60mg
adults and children 12 years of age and over	take two 60mg tablets with water evrery 12 hours; 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

	NDC
1	69230-201-01
2	69230-201-05
3	69230-202-01
4	69230-202-05
5	69230-202-11
6	69230-202-30
7	69230-202-45
8	69230-202-60
9	69230-202-90

Label: FEXOFENADINE HCL tablet, film coated

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 a 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 HCL tablet, film coated

Number of versions: 3

FEXOFENADINE HCL tablet, film coated

FEXOFENADINE HCL tablet, film coated

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FEXOFENADINE HCL tablet, film coated

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