![12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MEIJER DISTRIBUTION INC]](https://medic.hrt.org//dailymed/images/8fb2d2cf-d45b-4df4-9a4d-1292a2596445/0546E-12hour-descongestant-image1.jpg)
| NDC | 41250-054-52, 41250-054-60 |
| Set ID | 8fb2d2cf-d45b-4df4-9a4d-1292a2596445 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Meijer Distribution Inc |
| Generic Name | |
| Product Class | alpha-Adrenergic Agonist |
| Product Number | |
| Application Number | ANDA075153 |
- Active ingredient (in each tablet)
- Purpose
- Uses
- •
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- •
- temporarily relieves sinus congestion and pressure
- Warnings
Do not use
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
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- •
- nervousness, dizziness, or sleeplessness occur
- •
- symptoms do not improve within 7 days or occur with a fever
CloseKeep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- Directions
Close
adults and children 12 years and over
- •
- take 1 tablet every 12 hours
- •
- do not take more than 2 tablets in 24 hours
children under 12 years
do not use this product in children under 12 years of age
- Other information
- •
- each tablet contains: calcium 45 mg
- •
- store at 20 - 25°C (68 - 77°F) in a dry place
- •
- protect from light
- •
- do not use if blister unit is broken or torn
- •
- see carton end panel for lot number and expiration date
- •
- this product meets the requirements of USP Drug Release Test 3
- Inactive ingredients
carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
Close - Questions or comments?
- Principal Display Panel
Compare to Sudafed® 12 Hour active ingredient
Non-Drowsy
Sinus
12Hour Decongestant
Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg
Long-Acting Nasal Decongestant
Maximum Strength
Sinus Pressure + Congestion
Pseudoephedrine HCl
20 Coated Caplets* 120 mg Each
Actual Size
*capsule shaped tablets
Close - INGREDIENTS AND APPEARANCE
12 HOUR DECONGESTANT
pseudoephedrine hydrochloride tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-054 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code L054 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-054-60 20 in 1 CARTON 11/05/1999 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41250-054-52 10 in 1 CARTON 07/12/2004 2 1 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 ANDA075153 11/05/1999 CloseLabeler - Meijer Distribution Inc (006959555)
