FDA Label for Sinus Pe Congestion Daytime Nighttime
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET) (SINUS DAY)
- PURPOSE
- ACTIVE INGREDIENTS (IN EACH TABLET) (SINUS NIGHT)
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS (DAYTIME ONLY)
- INACTIVE INGREDIENTS (NIGHTTIME ONLY)
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Sinus Pe Congestion Daytime Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Meijer Distribution, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet) (Sinus Day)
Phenylephrine HCl 10 mg
Purpose
Nasal decongestant
Antihistamine
Nasal decongestant
Active Ingredients (In Each Tablet) (Sinus Night)
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
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
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)
Stop Use And Ask A Doctor If
- symptoms do not improve within 7 days or occur with fever
- nervousness, dizziness, or sleeplessness occur
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.
Directions
- adults and children 12 years and over
- take 1 tablet every 4 hours
- do not take more than 6 tablets in 24 hours
- take 1 tablet every 4 hours
- children under 12 years: do not use
Other Information
- each tablet contains: calcium 25 mg (Nighttime only)
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients (Daytime Only)
croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide
Inactive Ingredients (Nighttime Only)
croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin
Questions Or Comments?
1-800-426-9391
Principal Display Panel
meijer®
COMBO PACK
20 TABLETS TOTAL
NDC 79481-4534-1
COMPARE TO
DAYTIME SUDAFED PE®
SINUS CONGESTION ACTIVE INGREDIENT*
COMPARE TO
NIGHTTIME SUDAFED PE®
SINUS CONGESTION
ACTIVE INGREDIENTS*
NON-DROWSY Daytime PHENYLEPHRINE HCI 10 mg Pseudoephedrine Free Relieves 12 | Nighttime DIPHENHYDRAMINE HCl 25 mg Pseudoephedrine Free Relieves 8 |
TAMPER 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 Kenvue Inc., owner
of the registered trademark Sudafed
PE® Sinus Congestion Daytime
and Nighttime.
50844 ORG082045348509
DIST. BY MEIJER
DISTRUBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com
Do not take the Daytime and Nighttime
tablets at the same time.
* Please review the disclaimer below.