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SINUS + HEADACHE DAY
Drug Facts
SINUS + HEADACHE NIGHT
Drug Facts
Sinus Plus Headache Day And Night
FDA Label NDC 36800-349
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Sinus Plus Headache Day And Night (NDC 36800-349). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each day caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Phenylephrine HCl 5 mg | Nasal decongestant |
| Active ingredients (in each night caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Chlorpheniramine maleate 2 mg | Antihistamine |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
■ temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
■ headache
■ sinus congestion and pressure
■ nasal congestion
■ minor aches and pains
■ helps decongest sinus openings and passages
■ promotes sinus drainage
■ helps clear nasal passages
■ temporarily reduces fever
■ temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
■ headache
■ sinus congestion and pressure
■ nasal congestion
■ runny nose and sneezing
■ minor aches and pains
■ helps decongest sinus openings and passages
■ promotes sinus drainage
■ helps clear nasal passages
■ temporarily reduces fever
Liver Warning
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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
■ 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.
■ if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
■ liver disease
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
When Using This Product
■
do not exceed recommended dosage
In addition, when using Sinus + Headache Night:
■ excitability may occur, especially in children
■ drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ avoid alcoholic drinks
■ be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
■ nervousness, dizziness, or sleeplessness occur
■ pain or nasal congestion 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
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Overdose Warning
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 Day and Night caplets at the same time
■ do not take more than a total of 10 caplets in 24 hours
| adults and children 12 years and over |
|
| children under 12 years |
|
Other Information
■ store between 20-25°C (68-77°F) in a dry place
■ retain carton for complete product information and warnings
Sinus + Headache Day
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
Sinus + Headache Night
acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
Principal Display Panel
TopCare® health
NDC 36800-349-02
For Adults
Sinus + Headache Day + Night
DAYTIME
NON-DROWSY
PAIN RELIEVER/FEVER REDUCER - ACETAMINOPHEN
NASAL DECONGESTANT - PHENYLEPHRINE HCl
DAY CAPLET RELIEVES:
• Sinus Headache
• Sinus Pressure
• Nasal Congestion
actual size
12 COOL TASTE CAPLETS
NIGHTTIME
PAIN RELIEVER/FEVER REDUCER - ACETAMINOPHEN
NASAL DECONGESTANT - PHENYLEPHRINE HCl
ANTIHISTAMINE* - CHLORPHENIRAMINE MALEATE*
NIGHT CAPLET RELIEVES:
• Sinus Headache
• Sinus Pressure
• Nasal Congestion
• Runny Nose*
*Antihistamine in Nighttime Only
actual size
8 COOL TASTE CAPLETS
Image Description (F1149b02tcr R1)
* Please review the disclaimer below.
