Label: UP AND UP ALLERGY AND CONGESTION RELIEF- loratadine and pseudoephedrine sulfate tablet, extended release
- NDC Code(s): 11673-013-39, 11673-013-60
- Packager: Target Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients (in each tablet)
Loratadine 5 mg
Pseudoephedrine sulfate 120 mgClose
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- 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
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
- 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
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)
- 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 orkidney 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 dioxideClose
- Package/Label Principal Display Panel
allergy and congestion relief
pseudoephedrine sulfate 120 mg/nasal decongestant
loratadine 5 mg/antihistamine
extended release tablets
Compare to active ingredients in Claritin-D® 12 Hour
original prescription strength
indoor and outdoor allergies
nasal and sinus congestion due to colds or allergies
sneezing/runny nose/itchy, watery eyes/itchy throat or nose due to allergies
*when taken as directed.
see drug facts panel.
SHOWN ACTUAL SIZE ABOVE
Allergy and Congestion Relief Carton Image 1
Allergy and Congestion Relief Carton Image 2
- INGREDIENTS AND APPEARANCE
UP AND UP ALLERGY AND CONGESTION RELIEF
loratadine, pseudoephedrine tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-013 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 5 mg PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE 120 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape ROUND Size 12mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-013-60 2 in 1 CARTON 1 10 in 1 BLISTER PACK 2 NDC:11673-013-39 3 in 1 CARTON 2 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076050 03/12/2012 Labeler - Target Corporation (006961700)