Label: SINUS PE CONGESTION DAYTIME NIGHTTIME- diphenhydramine hcl, phenylephrine hcl kit
- NDC Code(s): 79481-4534-1, 79481-7453-2, 79481-7485-3
- Packager: Meijer Distribution, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 29, 2024
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
meijer®
COMBO PACK
20 TABLETS TOTALNDC 79481-4534-1
COMPARE TO
DAYTIME SUDAFED PE®
SINUS CONGESTION
ACTIVE INGREDIENT*NON-DROWSY
Daytime
Sinus PE CongestionPHENYLEPHRINE HCI 10 mg
NASAL DECONGESTANTPseudoephedrine Free
Relieves
Nasal Congestion12
Tablets
actual sizeCOMPARE TO
NIGHTTIME SUDAFED PE®
SINUS CONGESTION
ACTIVE INGREDIENTS*Nighttime
Sinus PE CongestionDIPHENHYDRAMINE HCl 25 mg
PHENYLEPHRINE HCl 10 mg
Antihistamine
Nasal DecongestantPseudoephedrine Free
Relieves
Nasal Congestion,
Runny Nose8
Tablets
actual sizeTAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERINGDo not take the Daytime and Nighttime
tablets at the same time.*This product is not manufactured
or distributed by Kenvue Inc., owner
of the registered trademark Sudafed
PE® Sinus Congestion Daytime
and Nighttime.50844 ORG082045348509
DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.commeijer 44-453485
-
INGREDIENTS AND APPEARANCE
SINUS PE CONGESTION DAYTIME NIGHTTIME
diphenhydramine hcl, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-4534 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-4534-1 1 in 1 CARTON; Type 0: Not a Combination Product 07/05/2023 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 SINUS PE CONGESTION DAYTIME
phenylephrine hcl tablet, film coatedProduct Information Item Code (Source) NDC:79481-7453 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 NDC:79481-7453-2 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 07/05/2023 Part 2 of 2 SINUS PE CONGESTION NIGHTTIME
diphenhydramine hcl, phenylephrine hcl tablet, film coatedProduct Information Item Code (Source) NDC:79481-7485 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 NDC:79481-7485-3 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 07/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/05/2023 Labeler - Meijer Distribution, Inc. (006959555) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(79481-4534) , pack(79481-4534) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(79481-4534) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(79481-4534) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(79481-4534)