![SUNMARK ALL DAY ALLERGY D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]](https://medic.hrt.org//dailymed/images/f1ac3a42-d802-4ffb-9bc1-28529775d8fa/lbl500902537.jpg)
| NDC | 50090-2537-1 |
| Set ID | f1ac3a42-d802-4ffb-9bc1-28529775d8fa |
| Category | HUMAN OTC DRUG LABEL |
| Packager | A-S Medication Solutions |
| Generic Name | |
| Product Class | alpha-Adrenergic Agonist |
| Product Number | |
| Application Number | ANDA077170 |
- Active ingredient (in each extended release tablet)
- Purpose
-
Uses
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- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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- runny nose
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- sneezing
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- itchy, watery eyes
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- itching of the nose or throat
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- nasal congestion
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- reduces swelling of nasal passages
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- temporarily relieves sinus congestion and pressure
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- temporarily restores freer breathing through the nose
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Warnings
Do not use
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- if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
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- 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
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- heart disease
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- thyroid disease
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- diabetes
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- glaucoma
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- high blood pressure
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- trouble urinating due to an enlarged prostate gland
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- liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product
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- do not use more than directed
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- drowsiness may occur
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- avoid alcoholic drinks
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
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- an allergic reaction to this product occurs. Seek medical help right away.
- •
- you get nervous, dizzy, or sleepless
- •
- symptoms do not improve within 7 days or are accompanied by fever
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- HOW SUPPLIED
- Cetirizine HCl, Pseudoephedrine HCl
-
INGREDIENTS AND APPEARANCE
SUNMARK ALL DAY ALLERGY D
cetirizine hcl, pseudoephedrine hcl tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-2537(NDC:49348-851) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 5 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color WHITE (one side white one side light yellow) Score no score Shape ROUND Size 12mm Flavor Imprint Code 5029;5;120 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-2537-1 4 in 1 CARTON 10/19/2016 1 6 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 ANDA077170 04/18/2008 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-2537)
