54868-5884 : Cetirizine Dihydrochloride 5 mg / Pseudoephedrine Hydrochloride 120 mg 12 Hr Extended Release Tablet
| NDC: | 54868-5884 |
| Labeler: | Physicians Total Care, Inc. |
| Product Type: | Human OTC Drug |
| Drug Name: |  Cetirizine Hcl and Pseudoephedrine Hcl ER |
| Dosage Form: | Oral Tablet, Film Coated, Extended Release |
| Application #: | ANDA077991 |
| Rev. Date: | |
| CSA Schedule: | CV (US) [1] |
[1] Schedule V Controlled Substance: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. (i.e. Cough preparations containing not more than 200 milligrams of Codeine per 100 milliliters or per 100 grams [such as Robitussin AC, Phenergan with Codeine], and Ezogabine). More Details: US Dept of Justice Controlled Substance Schedules.
Appearance:
| Markings: | SZ912 |
| Shapes: |
Round |
| Colors: |
 Yellow |
| Size (mm): | 10 |
| Segments: * | 1 |
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines. | |
NDC Package Codes:
- 54868-5884-0: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (54868‑5884‑0)
- 54868-5884-1: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (54868‑5884‑1)
- 54868-5884-2: 4 BLISTER PACK IN 1 CARTON (54868‑5884‑2) > 6 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BLISTER PACK
Active Ingredients:
- Cetirizine Hydrochloride
- Pseudoephedrine Hydrochloride
Dosage Strength:
- 5 mg
- 120 mg
Inactive Ingredients:
- Silicon Dioxide
- Croscarmellose Sodium
- D&c Yellow No. 10
- Ferric Oxide Red
- Ferric Oxide Yellow
- Hypromellose 2208 (15000 Cps)
- Lactose Monohydrate
- Magnesium Stearate
- Cellulose, Microcrystalline
- Polyethylene Glycol
- Polysorbate 80
- Povidone
- Titanium Dioxide
Related Products:
Based on records with the same trade name.- 63629-4399 Cetirizine Dihydrochloride 5 mg / Pseudoephedrine Hydrochloride 120 mg 12 Hr Extended Release Tablet by Bryant Ranch Prepack
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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.