Label: 12 HOUR ALLERGY D- cetirizine hcl, pseudoephedrine hcl tablet, extended release
- NDC Code(s): 41250-299-53, 41250-299-62
- Packager: Meijer Distribution Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 17, 2018
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- Active ingredient (in each extended release tablet)
Cetirizine HCl 5 mg
Pseudoephedrine HCl 120 mgClose
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- 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
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
- 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
Stop use and ask a doctor if
- 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
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: 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.
- do not break or chew tablet; swallow tablet whole
adults and children 12 years and over
take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and over
ask a doctor
children under 12 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
- Other information
- store between 20° to 25°C (68° to 77°F)
- Inactive ingredients
colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxideClose
- Questions or comments?
- Principal Display Panel
Compare to Zyrtec-D® active ingredients
ALLERGY & CONGESTION
12 Hour Allergy-D
Cetirizine Hydrochloride and Pseudoephedrine Hyrdochloride
Extended Release Tablets 5 mg/120 mg
Indoor & Outdoor Allergies
12 Hour Relief of:
Itchy, Watery Eyes
Itchy Throat or Nose
Original Prescription StrengthClose
- INGREDIENTS AND APPEARANCE
12 HOUR ALLERGY D
cetirizine hcl, pseudoephedrine hcl tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-299 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) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (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:41250-299-53 2 in 1 CARTON 05/14/2008 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41250-299-62 4 in 1 CARTON 05/14/2008 2 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 07/15/1988 Labeler - Meijer Distribution Inc (006959555)