Alavert®

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg) Pseudoephedrine (120 mg)

Inactive Ingredients

Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Povidone, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 7U0 Shape: round Color: white Size: 14 mm Score: 1

Marketing Status

ANDA Active Since 2021-12-15

Medication Information

Description

Drug Facts

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- 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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50567-7

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Active ingredients (in each tablet)	Purposes
Loratadine 5 mg	Antihistamine
Pseudoephedrine sulfate 120 mg	Nasal decongestant

Directions

do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over	1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

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.

Other Information

each tablet contains: calcium 25 mg
store between 20° to 25°C (68° to 77°F)
keep in a dry place

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

Questions Or Comments?

Call 1-800 ALAVERT (1-800-252-8378) weekdays 9 AM to 5 PM EST

Stop Use and Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.
symptoms do not improve within 7 days or are accompanied by a fever
nervousness, dizziness or sleeplessness occurs

Ask A Doctor Before Use If You Have

heart disease
thyroid disease
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
liver or kidney disease. Your doctor should determine if you need a different dose.

Principal Display Panel 24 Tablet Blister Pack Carton

Compare ours to the Active Ingredients in

Claritin-D^® 12 Hour Tablets^†

allergy & congestion

ALAVERT^®

D-12

HOUR

Pseudoephedrine Sulfate 120 mg/Nasal Decongestant

Loratadine 5 mg/Antihistamine – Extended Release Tablets

Non-Drowsy*

Relief of:

• Nasal and Sinus Congestion Due to Colds or Allergies

• Sneezing • Runny Nose • Itchy, Watery Eyes

• Itchy Throat or Nose Due to Allergies

Indoor & Outdoor Allergies

*When taken as directed. See Drug Facts Panel.

24 TABLETS

Actual Size

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- 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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50567-7 (50567-7)

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredients (in each tablet)	Purposes
Loratadine 5 mg	Antihistamine
Pseudoephedrine sulfate 120 mg	Nasal decongestant

Directions

do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over	1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Do Not Use (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.

Other Information (Other information)

each tablet contains: calcium 25 mg
store between 20° to 25°C (68° to 77°F)
keep in a dry place

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800 ALAVERT (1-800-252-8378) weekdays 9 AM to 5 PM EST

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.
symptoms do not improve within 7 days or are accompanied by a fever
nervousness, dizziness or sleeplessness occurs

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

heart disease
thyroid disease
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
liver or kidney disease. Your doctor should determine if you need a different dose.

Principal Display Panel 24 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton)

Compare ours to the Active Ingredients in

Claritin-D^® 12 Hour Tablets^†

allergy & congestion

ALAVERT^®

D-12

HOUR

Pseudoephedrine Sulfate 120 mg/Nasal Decongestant

Loratadine 5 mg/Antihistamine – Extended Release Tablets

Non-Drowsy*

Relief of:

• Nasal and Sinus Congestion Due to Colds or Allergies

• Sneezing • Runny Nose • Itchy, Watery Eyes

• Itchy Throat or Nose Due to Allergies

Indoor & Outdoor Allergies

*When taken as directed. See Drug Facts Panel.

24 TABLETS

Actual Size

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "120", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itchy, watery eyes runny nose 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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each tablet) Purposes Loratadine 5 mg Antihistamine Pseudoephedrine sulfate 120 mg Nasal decongestant", "Directions": "do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "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.", "Other information": "each tablet contains: calcium 25 mg store between 20° to 25°C (68° to 77°F) keep in a dry place", "Inactive ingredients": "croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide", "Questions or comments?": "Call 1-800 ALAVERT (1-800-252-8378) weekdays 9 AM to 5 PM EST", "Stop use and ask a doctor if": "an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs", "Ask a doctor before use if you have": "heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose.", "PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton": "Compare ours to the Active Ingredients in Claritin-D ® 12 Hour Tablets † allergy & congestion ALAVERT ® D-12 HOUR Pseudoephedrine Sulfate 120 mg/Nasal Decongestant Loratadine 5 mg/Antihistamine – Extended Release Tablets Non-Drowsy* Relief of: • Nasal and Sinus Congestion Due to Colds or Allergies • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose Due to Allergies Indoor & Outdoor Allergies *When taken as directed. See Drug Facts Panel. 24 TABLETS Actual Size"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information