FDA Label for Daytime Nighttime Sinus Relief Maximum Strength
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS IN DAYTIME (IN EACH SOFTGEL)
- ACTIVE INGREDIENTS IN NIGHTTIME (IN EACH SOFTGEL)
- PURPOSE FOR DAYTIME
- PURPOSE FOR NIGHTTIME
- USES
- WARNINGS
- 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
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Daytime Nighttime Sinus Relief Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. 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 Ingredients In Daytime (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Active Ingredients In Nighttime (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCI 5 mg
Purpose For Daytime
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Purpose For Nighttime
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
DAYTIME
- temporarily relieves
- nasal congestion
- headache
- cough due to inhaled irritants
- sinus congestion and pressure
- minor aches and pains
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves
- nasal congestion
- cough due to inhaled irritants
- headache
- sinus congestion and pressure
- minor aches and pains
- runny nose and sneezing
- promotes nasal and/or sinus drainage
NIGHTTIME
Warnings
DAYTIME and NIGHTTIME
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away
Do Not Use
DAYTIME and NIGHTTIME
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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
DAYTIME
- liver disease
- high blood pressure
- diabetes
- heart disease
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- liver disease
- high blood pressure
- diabetes
- heart disease
- thyroid disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus
NIGHTTIME
Ask A Doctor Or Pharmacist Before Use If You Are
DAYTIME
taking the blood thinning drug warfarin
NIGHTTIME
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product,
DAYTIME
do not use more than directed
NIGHTTIME
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
DAYTIME and NIGHTTIME
- nervousness, dizziness, or sleeplessness
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts. These coukld be signs of a serious condition.
If Pregnant Or Breast-Feeding,
DAYTIME and NIGHTTIME
ask a health professional before use.
Keep Out Of Reach Of Children.
DAYTIME and NIGHTTIME
Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
DAYTIME
- do not take more than directed (see Overdose warning)
- do not take more than 12 softgels (Daytime and NightTime) in any 24-hour period
- adults and children 12 years of age and older: take 2 softgels every 4 hours
- children under 12 years of age: do not use
- when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
- do not take more than directed (see Overdose warning)
- do not take more than 12 softgels (Daytime and Nighttime) in any 24-hour period
- adults and children 12 years of age and older: take 2 softgels every 4 hours
- children under 12 years of age: do not use
- when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
NIGHTTIME
Other Information
DAYTIME and NIGHTTIME
- swallow whole; do not crush, chew, or dissolve
- store between 15-30°C (59-86F)
- avoid excessive heat
Inactive Ingredients
DAYTIME
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide
NIGHTTIME
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitan*, sorbitol, titanium dioxide
Questions Or Comments?
DAYTIME and NIGHTTIME
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
DAYTIME
Sinus Relief
Acetaminophen / Pain Reliever
Dextromethorphan HBr / Cough Suppressant
Guaifenesin / Expectorant
Phenylephrine HCI / Nasal Decongestant
MAXIMUM STRENGTH
ALCOHOL FREE
- Relieves sinus pressure, headache & congestion
- Controls cough
- thins & loosens mucus
- For ages 12 years & over
- Relieves nasal congestion, sinus pressure & pain, runny nose & sneezing
- Controls cough
- For ages 12 years & over
SOFTGELS*
NIGHTTIME
Sinus Relief
Acetaminophen / Pain Reliever
Dextromethorphan HBr/ Cough Suppressant
Doxylamine Succinate / Antihistamine
Phenylephrine HCI / Nasal Decongestant
MAXIMUM STRENGTH
ALCOHOL FREE
SOFTGELS*
(*LIQUID-FILLED CAPSULES)
Compare to Maximum Strength Mucinex® Sinus-Max® Day & Mucinex® Sinus-Max® Night active ingredients≠≠
≠≠This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Sinus-Max® Day and Maximum Strength Mucinex® Sinus-Max® Night.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
Product Label
WALGREENS Daytime Nighttime Sinus Relief
* Please review the disclaimer below.