Signature Care Allergy and Congestion Relief: Package Insert and Label Information

SIGNATURE CARE ALLERGY AND CONGESTION RELIEF- loratadine and pseudoephedrine sulfate tablet, film coated, extended release
Safeway

Active ingredients (in each tablet)

Loratadine 5 mg

Pseudoephedrine sulfate 120 mg

Purpose

Antihistamine

Nasal decongestant

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

Warnings

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.

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.

When using this product do not take more than directed.

Taking more than directed may cause drowsiness.

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).

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

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?

1-888-723-3929

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Compare to Claritin-D® 12 hour Extended Release Tablets active ingredients

Quality Guaranteed

12 HOUR | NON-DROWSY*

Allergy & Congestion Relief

PSEUDOEPHEDRINE SULFATE 120 mg/LORATADINE 5 mg

EXTENDED RELEASE TABLETS

Nasal Decongestant/Antihistamine

Actual Size

Indoor & Outdoor Allergies

Relief of:

Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing — Runny Nose — Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

20 TABLETS

*When taken as directed. See Drug Facts Panel.

allergy and congestion relief image
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SIGNATURE CARE ALLERGY AND CONGESTION RELIEF
loratadine, pseudoephedrine sulfate tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-482
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 5 mg
PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE 120 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (to off-white) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code 7U0
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21130-482-60 20 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (21130-482-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076050 04/02/2018
Labeler — Safeway (009137209)

Revised: 11/2020 Safeway

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