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NDC 36800-0569-01 Sinus Relief Day and Night Details
Sinus Relief Day and Night
Sinus Relief Day and Night is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by TopCo Associates LLC. 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: 36800-0569-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine 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: 36800-0569-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
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: 36800-0569-01Last 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: 36800-0569-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 36800-0569 |
|---|---|
| Product ID | 36800-569_d0e83853-d495-db58-e053-2a95a90a8dae |
| 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 | Sinus Relief Day and Night |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | KIT |
| Route | n/a |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | TopCo Associates LLC |
| 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 36800-0569-01 (36800056901)
| NDC Package Code | 36800-569-01 |
|---|---|
| Billing NDC | 36800056901 |
| Package | 1 KIT in 1 CARTON (36800-569-01) * 10 TABLET, COATED in 1 BLISTER PACK * 10 TABLET, COATED in 1 BLISTER PACK |
| Marketing Start Date | 2017-06-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 55762d52-a35b-4087-b133-a9f446f64f7f Details
SPL UNCLASSIFIED SECTION
Uses
- temporarily relieves:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
- runny nose and sneezing (SINUS NIGHT ONLY)
- 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 (SINUS DAY ONLY)
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on skin (SINUS NIGHT 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.
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- glaucoma (SINUS NIGHT ONLY)
- a breathing problem such as emphysema or chronic bronchitis (SINUS NIGHT ONLY)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (SINUS DAY ONLY)
- cough that occurs with too much phlegm (mucus) (SINUS DAY ONLY)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (SINUS NIGHT ONLY)
When using this product
- do not use more than directed
- excitability may occur, especially in children (SINUS NIGHT ONLY)
- marked drowsiness may occur (SINUS NIGHT ONLY)
- alcohol, sedatives, and tranquilizers may increase drowsiness (SINUS NIGHT ONLY)
- avoid alcoholic drinks (SINUS NIGHT ONLY)
- be careful when driving a motor vehicle or operating machinery (SINUS NIGHT ONLY)
Stop use and ask a doctor if
- 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 persistent headache
These could be signs of a serious condition.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see Overdose warning)
- do not take Sinus Day and Sinus Night caplets at the same time
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years and older: take 2 caplets every 4 hours
- children under 12 years of age: do not use
Other information
Inactive ingredients
SINUS DAY
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
PRINCIPAL DISPLAY PANEL
NDC 36800-569-01
TopCare® Health
For Ages 12+
Compare to Mucinex® Sinus-Max™ Day & Night Active Ingredients*
Maximum Strength†
Sinus Relief Day & Night
Daytime
Pain Reliever – Acetaminophen
Expectorant – Guaifenesin
Nasal Decongestant – Phenylephrine HCl
Day Caplet Relieves:
Sinus Pressure
Headache & Congestion
Thins & Loosens Mucus
Nighttime
Pain Reliever – Acetaminophen
Antihistamine – Diphenhydramine HCl
Nasal Decongestant – Phenylephrine HCl
Night Caplet Relieves:
Nasal Congestion
Sinus Pressure & Pain
Runny Nose & Sneezing
Our Pharmacists Recommend
10 Day Caplets
10 Night Caplets
INGREDIENTS AND APPEARANCE
| SINUS RELIEF DAY AND NIGHT
acetaminophen, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit |
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| Labeler - TopCo Associates LLC (006935977) |