NDC | 0113-2008-62, 0113-2008-67, 0113-2008-80 |
Set ID | 2dd0e007-4aeb-4b51-815e-4ebe378a4095 |
Category | HUMAN OTC DRUG LABEL |
Packager | L. Perrigo Company |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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
-
Directions
adults and children 12
years and over
- •
- take 2 tablets every 4 to 6 hours
- •
- do not take more than 8 tablets in 24 hours
children ages 6 to 11
years
- •
- take 1 tablet every 4 to 6 hours
- •
- do not take more than 4 tablets in 24 hours
children under 6 years
do not use this product in children under 6 years of age
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
SINUS CONGESTION
pseudoephedrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-2008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape ROUND (convex) Size 7mm Flavor Imprint Code L432 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-2008-80 48 in 1 CARTON 10/04/2016 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0113-2008-67 24 in 1 CARTON 10/04/2016 2 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0113-2008-62 12 in 1 CARTON 10/04/2016 3 2 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 OTC monograph final part341 10/04/2016 Labeler - L. Perrigo Company (006013346)