ALLERGY RELIEF-D24 HOUR 24 HOUR- loratadine and pseudoephedrine sulfate tablet, extended release

Allergy Relief-D24 Hour by

Drug Labeling and Warnings

Allergy Relief-D24 Hour by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Teva Pharmaceuticals USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Loratadine, USP 10 mg
Pseudoephedrine sulfate, USP 240 mg

Purposes

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.

Directions

• do not divide, crush, chew or dissolve the tablet

• adults and children 12 years and over: 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
• children under 12 years of age: ask a doctor
• consumers with liver or kidney disease: ask a doctor

Other information

• safety sealed: do not use if blister unit is open or torn
• store between 20° to 25°C (68° to 77°F)
• protect from light and store in a dry place

Inactive ingredients

black iron oxide, candelilla wax powder, colloidal silicon dioxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, propylene glycol, sodium lauryl sulfate, talc and titanium dioxide

QUESTIONS

Questions? 1-888-838-2872 between 9 am and 5 pm ET, Monday – Friday.

PRINCIPAL DISPLAY PANEL

NDC: 36800-472-17

TopCarehealth™

COMPARE TO
CLARITIN-D® 24 HOUR
ACTIVE INGREDIENTS†

NON-DROWSY* EXTENDED-RELEASE TABLETS

Allergy Relief-D

LORATADINE, USP 10 mg  PSEUDOEPHEDRINE SULFATE, USP 240 mg
EXTENDED-RELEASE TABLETS
ANTIHISTAMINE  NASAL DECONGESTANT

INDOOR & OUTDOOR ALLERGIES

ALLERGY & CONGESTION

OUR PHARMACISTS RECOMMEND

24 HOUR RELIEF OF:

• Nasal & Sinus Congestion Due to Colds or Allergies
• Sneezing ● Runny Nose ● Itchy, Watery Eyes
• Itchy Throat or Nose Due to Allergies

10 EXTENDED-RELEASE TABLETS

*When taken as directed.
See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF-D24 HOUR  24 HOUR
loratadine and pseudoephedrine sulfate tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-472
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE SULFATE	240 mg

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CANDELILLA WAX (UNII: WL0328HX19)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (white to off-white)	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	Andrx;605
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-472-17	2 in 1 CARTON	03/21/2016
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 36800-472-18	3 in 1 CARTON	03/21/2016
2		5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075706	03/21/2016

Labeler - TOP CARE (Topco Associates LLC) (006935977)