Label: ALLERGY RELIEF-D- cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
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Contains inactivated NDC Code(s)
NDC Code(s): 70000-0163-1 - Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 27, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
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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:
- Warnings
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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) (cer tain 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
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding:
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions?
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Principal Display Panel - Showbox
LEADER
NDC 70000-0163-1
Allergy Relief-D
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP
5 mg/120 mg
Antihistamine | Nasal Decongestant
Original Prescription Strength
COMPARE TO ZYRTEC-D® 12 HOUR
active ingredients*
12 Hour Relief of:
• Sinus Pressure • Nasal Congestion
• Runny Nose • Sneezing
• Itchy, Watery Eyes
• Itchy Throat or Nose
24 EXTENDED-RELEASE TABLETS (4 blister cards of 6 tablets each)
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF-D
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0163 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 HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) AMMONIA (UNII: 5138Q19F1X) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45) Product Characteristics Color WHITE Score no score Shape ROUND (circular) Size 9mm Flavor Imprint Code 915 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0163-1 24 in 1 CARTON; Type 0: Not a Combination Product 05/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090922 05/02/2017 Labeler - Cardinal Health (097537435) Registrant - Sun Pharmaceutical Industries Limited (650172430) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 650445203 ANALYSIS(70000-0163) , MANUFACTURE(70000-0163)