Label: SINUS PRESSURE AND CONGESTION RELIEF- diphenhydramine hcl, phenylephrine hcl kit
- NDC Code(s): 11822-9485-9
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet) (Sinus Day)
- Purpose
- Active ingredients (in each tablet) (Sinus Night)
- Purpose
-
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- nasal congestion
- sneezing (Nighttime only)
- runny nose (Nighttime only)
- itchy, watery eyes (Nighttime only)
- itching of the nose or throat (Nighttime only)
- temporarily relieves these symptoms due to the common cold:
- nasal congestion
- sneezing (Nighttime only)
- runny nose (Nighttime only)
- temporarily relieves sinus congestion and pressure
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
-
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.
- with any other product containing diphenhydramine, even one used on skin (Nighttime only)
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
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- glaucoma (Nighttime only)
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers. (Nighttime only)
When using this product
-
do not exceed recommended dosage
- excitability may occur, especially in children (Nighttime only)
- marked drowsiness may occur (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
- avoid alcoholic beverages (Nighttime only)
- use caution when driving a motor vehicle or operating machinery (Nighttime only)
- 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.
- Directions
- Other information
- Inactive ingredients (Daytime only)
- Inactive ingredients (Nighttime only)
- Questions or comments?
-
Principal display panel
NDC 11822-9485-9
Compare to the active ingredients in Sudafed PE® Sinus Congestion Day + Night*SINUS PRESSURE &
CONGESTION RELIEF PEDAYTIME
PHENYLEPHRINE HCl
NASAL DECONGESTANT
NON-DROWSYRelieves nasal
congestionACTUAL SIZE
NIGHTTIME
DIPHENHYDRAMINE HCl
PHENYLEPHRINE HCl
ANTIHISTAMINE,
NASAL DECONGESTANTRelieves nasal
congestion,
runny noseACTUAL SIZE
12 DAYTIME
TABLETS8 NIGHTTIME
TABLETSTAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERINGDISTRIBUTED BY:
RITE AID, 200 NEWBERRY COMMONS
ETTERS, PA 17319 www.riteaid.comSATISFACTION
GUARANTEE
if you're not satisfied, we'll
happily refund your money.*The product is not manufactured or distributed by Johnson
& Johnson Corporation, owner of the registered trademark
SUDAFED PE® SINUS CONGESTION DAY + NIGHT50844 REV0820D45348509
Do Not Take Daytime and
Nighttime Products at the
Same TimeRite Aid 44-453485
-
INGREDIENTS AND APPEARANCE
SINUS PRESSURE AND CONGESTION RELIEF
diphenhydramine hcl, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-9485 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-9485-9 1 in 1 CARTON; Type 0: Not a Combination Product 07/02/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 12 Part 2 1 BLISTER PACK 8 Part 1 of 2 DAYTIME SINUS PRESSURE AND CONGESTION RELIEF
phenylephrine hcl tablet, film coatedProduct Information 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) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C RED NO. 40 (UNII: WZB9127XOA) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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 12 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 Drug M012 07/02/2019 Part 2 of 2 NIGHTTIME SINUS PRESSURE AND CONGESTION RELIEF
diphenhydramine hcl, phenylephrine hcl tablet, film coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color blue Score no score Shape OVAL Size 11mm Flavor Imprint Code 44;485 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 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 Drug M012 07/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/02/2019 Labeler - Rite Aid Corporation (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(11822-9485) , pack(11822-9485) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(11822-9485) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(11822-9485) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(11822-9485)