Label: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, film coated, extended release
- NDC Code(s): 29300-313-22, 29300-313-24, 29300-313-61
- Packager: Unichem Pharmaceuticals (USA), Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 23, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- PURPOSE
- SPL UNCLASSIFIED SECTION
-
USES
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- nasal congestion
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily restores freer breathing through the nose
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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WARNINGS
Do Not Use
- if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
- 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
- diabetes
- glaucoma
- 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 use more than directed
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- Keep out of reach of children
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29300-313 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI) HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White to Off White and White to Pale Yellow) Score no score Shape ROUND (Biconvex) Size 10mm Flavor Imprint Code U;313 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29300-313-24 4 in 1 CARTON 01/01/2025 1 NDC:29300-313-61 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:29300-313-22 2 in 1 CARTON 01/01/2025 2 NDC:29300-313-61 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 ANDA210507 09/10/2024 Labeler - Unichem Pharmaceuticals (USA), Inc. (181620514)
