fexofenadine hydrochloride tablets usp, 60mg and 180 mg

fexofenadine hydrochloride tablets usp, 60mg and 180 mg
SPL v3
SPL
SPL Set ID 1bb1bea3-b17d-4326-b037-7468add0df80
Route
oral
Published
Effective Date 2021-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fexofenadine (180 mg)
Inactive Ingredients
anhydrous lactose silicon dioxide starch, corn croscarmellose sodium lactose monohydrate stearic acid hypromellose, unspecified polyethylene glycol, unspecified ferric oxide red titanium dioxide ferric oxide yellow

Identifiers & Packaging

Pill Appearance
Imprint: SG;201 Shape: capsule Shape: oval Color: pink Size: 17 mm Size: 12 mm Score: 1
Marketing Status
anda active Since 2021-12-08

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 60mg and 180 mg


Medication Information

Warnings

Active Ingredient

Fexofenadine HCl USP, 60mg and 180 mg

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
Purpose

Antihistamine

Directions

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
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

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 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
Inactive Ingredients

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.

Description

Fexofenadine HCl USP, 60mg and 180 mg

Do Not Use

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

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 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

Questions Or Comments?

Call 1-888-588-1418

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA,

Made in USA

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).

Ask A Doctor Before Use If You Have

kidney disease. Your doctor should determine if you need a different dose.

Camber Consumer Care Compare to the Active Ingredient in Allegra® Allergy 24 Hour Tablets


Structured Label Content

Warnings

Active Ingredient (55106-9)

Fexofenadine HCl USP, 60mg and 180 mg

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
Purpose

Antihistamine

Directions

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
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

Other Information (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 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
Inactive Ingredients (Inactive ingredients)

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.

Do Not Use (Do not use)

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

Camber Consumer Care (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 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

Questions Or Comments? (Questions or comments?)

Call 1-888-588-1418

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA,

Made in USA

When Using This Product (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 (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away (1800-222-1222).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

kidney disease. Your doctor should determine if you need a different dose.

Camber Consumer Care Compare to the Active Ingredient in Allegra® Allergy 24 Hour Tablets (Camber Consumer Care - Compare to the active ingredient in Allegra® Allergy 24 Hour Tablets)


Advanced Ingredient Data


Raw Label Data

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