Cvs Pharmacy, Inc. Allergy Relief-d12 Drug Facts

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: 12 mm Score: 1

Marketing Status

ANDA Active Since 2018-04-19

Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Loratadine 5 mg Pseudoephedrine sulfate 120 mg

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

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
•
do not use if blister unit is broken or torn
•
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?

1-800-719-9260

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

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 (1-800-222-1222).

Active Ingredients (in Each Tablet)

Loratadine 5 mg

Pseudoephedrine sulfate 120 mg

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.

Package/label Principal Display Panel

Compare to the active ingredients in Claritin-D^® 12 hour

Indoor & Outdoor Allergies

Non-Drowsy*

Allergy Relief-D12

12 HOUR

PSEUDOEPHEDRINE SULFATE 120 mg/Nasal decongestant

LORATADINE 5 mg/Antihistamine

EXTENDED RELEASE TABLETS

12 hour relief of:

Nasal & sinus congestion due to colds or allergies

Sneezing; Runny nose; Itchy, watery eyes; Itchy throat or nose due to allergies

Allergy & Congestion

20 EXTENDED RELEASE TABLETS

Actual Size

*When taken as directed.

See Drug Facts Panel.

When Using This Product Do Not Take More Than Directed.

Taking more than directed may cause drowsiness.

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

Purpose

Antihistamine

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
•
do not use if blister unit is broken or torn
•
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?)

1-800-719-9260

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

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 (1-800-222-1222).

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Loratadine 5 mg

Pseudoephedrine sulfate 120 mg

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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to the active ingredients in Claritin-D^® 12 hour

Indoor & Outdoor Allergies

Non-Drowsy*

Allergy Relief-D12

12 HOUR

PSEUDOEPHEDRINE SULFATE 120 mg/Nasal decongestant

LORATADINE 5 mg/Antihistamine

EXTENDED RELEASE TABLETS

12 hour relief of:

Nasal & sinus congestion due to colds or allergies

Sneezing; Runny nose; Itchy, watery eyes; Itchy throat or nose due to allergies

Allergy & Congestion

20 EXTENDED RELEASE TABLETS

Actual Size

*When taken as directed.

See Drug Facts Panel.

When Using This Product Do Not Take More Than Directed. (When using this product do not take more than directed.)

Taking more than directed may cause drowsiness.

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", "Purpose": "Antihistamine 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 • do not use if blister unit is broken or torn • 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?": "1-800-719-9260", "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", "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 (1-800-222-1222).", "Active ingredients (in each tablet)": "Loratadine 5 mg Pseudoephedrine sulfate 120 mg", "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.", "Package/Label Principal Display Panel": "Compare to the active ingredients in Claritin-D ® 12 hour Indoor & Outdoor Allergies Non-Drowsy* Allergy Relief-D12 12 HOUR PSEUDOEPHEDRINE SULFATE 120 mg/Nasal decongestant LORATADINE 5 mg/Antihistamine EXTENDED RELEASE TABLETS 12 hour relief of: Nasal & sinus congestion due to colds or allergies Sneezing; Runny nose; Itchy, watery eyes; Itchy throat or nose due to allergies Allergy & Congestion 20 EXTENDED RELEASE TABLETS Actual Size *When taken as directed. See Drug Facts Panel.", "When using this product do not take more than directed.": "Taking more than directed may cause drowsiness."}

Cvs Pharmacy, Inc. Allergy Relief-d12 Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information