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NDC 00363-0622-24 Daytime Nighttime Sinus Relief Details
Daytime Nighttime Sinus Relief
Daytime Nighttime Sinus Relief is a ORAL KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is .
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 00363-0622-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 00363-0622-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 00363-0622-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 00363-0622-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 00363-0622-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00363-0622 |
|---|---|
| Product ID | 0363-0622_3b91d47d-8520-4a55-aea6-05c218456e6e |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Daytime Nighttime Sinus Relief |
| Proprietary Name Suffix | Maximum Strength |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl,Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | KIT |
| Route | ORAL |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | Walgreens |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 00363-0622-24 (00363062224)
| NDC Package Code | 0363-0622-24 |
|---|---|
| Billing NDC | 00363062224 |
| Package | 1 KIT in 1 KIT (0363-0622-24) * 8 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2018-12-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bdb36ec8-27b4-46e0-b19d-0dce1b68b0aa Details
Active ingredients in Daytime (in each softgel)
Active ingredients in Nighttime (in each softgel)
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
NIGHTTIME
- 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
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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
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)
NIGHTTIME
- 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
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 occur
- 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.
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
NIGHTTIME
- 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
Other information
Inactive ingredients
DAYTIME
FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitiol*, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide
*may contain this ingredient
NIGHTTIME
D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol*, polyethylene glycol, povidone, propylene glycol, purified water, shellac*, sodium hydroxide*, sorbitan*, sorbitol, titanium dioxide
*contains one or more of these ingredients
Principal Display Panel
Compare to Maximum Strength Mucinex® Sinus-Max® Day & Mucinex® Sinus-Max® Night active ingredients††
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
- Ages 12 years & over
SOFTGELS**
(**LIQUID-FILLED CAPSULES)
NIGHTTIME
Sinus Relief
ACETAMINOPHEN / PAIN RELIEVER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
DOXYLAMINE SUCCINATE / ANTIHISTAMINE
PHENYLEPHRINE HCI / NASAL DECONGESTANT
MAXIMUM STRENGTH
ALCOHOL FREE
- Relieves nasal congestion, sinus pressure & pain, runny nose & sneezing
- Controls cough
- Ages 12 years & over
SOFTGELS*
(*LIQUID-FILLED CAPSULES)
≠≠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 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
INGREDIENTS AND APPEARANCE
| DAYTIME NIGHTTIME SINUS RELIEF
MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin kit |
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| Labeler - Walgreens (008965063) |