NDC | 11822-4530-2, 11822-4530-4, 11822-4530-7 |
Set ID | fccea3c5-42af-4939-82bc-d9409b75f91f |
Category | HUMAN OTC DRUG LABEL |
Packager | Rite Aid Corporation |
Generic Name | |
Product Class | alpha-1 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
- diabetes
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
NDC 11822-4530-7
Compare to the active ingredient in
Sudafed PE® Sinus Congestion*
MAXIMUM STRENGTH
SINUS PRESSURE &
CONGESTION
RELIEF PEPHENYLEPHRINE HCl 10 mg
NASAL DECONGESTANTRelieves sinus pressure, sinus and nasal congestion
Pseudoephedrine freeNON-DROWSY
ACTUAL SIZE
36
TABLETSTAMPER EVIDENT: DO NOT USE IF PACKAGE
IS OPENED OR IF BLISTER UNIT IS TORN,
BROKEN OR SHOWS ANY SIGNS OF TAMPERING*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the
registered trademark Sudafed PE® Sinus Congestion.
50844 REV0820F45307DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.comSATISFACTION GUARANTEE
If you’re not satisfied, we’ll
happily refund your money.Rite Aid 44-453 REV0820F
-
INGREDIENTS AND APPEARANCE
SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH
phenylephrine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-4530 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) Product Characteristics Color red Score no score Shape ROUND Size 7mm Flavor Imprint Code 44;453 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-4530-7 2 in 1 CARTON 01/14/2005 1 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:11822-4530-2 3 in 1 CARTON 01/14/2005 2 24 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:11822-4530-4 1 in 1 CARTON 01/14/2005 3 18 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 01/14/2005 Labeler - Rite Aid Corporation (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(11822-4530) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(11822-4530) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(11822-4530) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(11822-4530) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(11822-4530)