FDA Label for Harris Teeter Sinus Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPLET) SINUS RELIEF DAY
- PURPOSES
- ACTIVE INGREDIENTS (IN EACH CAPLET) SINUS RELIEF NIGHT
- 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 THESE PRODUCTS
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS (DAY ONLY)
- INACTIVE INGREDIENTS (NIGHT ONLY)
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Harris Teeter Sinus Relief Product Label
The following document was submitted to the FDA by the labeler of this product Harris Teeter, Llc. 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 Each Caplet) Sinus Relief Day
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Purposes
Pain reliever
Expectorant
Nasal decongestant
Pain reliever
Antihistamine/cough suppressant
Nasal decongestant
Active Ingredients (In Each Caplet) Sinus Relief Night
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Uses
• temporarily relieves:• nasal congestion• headache• minor aches and pains• sinus congestion and pressure• runny nose and sneezing (NIGHT only)• cough (NIGHT only)• temporarily 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 (DAY only)
Warnings
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 these products• 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
• 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 (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 these products.• if you have ever had an allergic reaction to these products or any of their ingredients
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 (NIGHT only)• a breathing problem such as emphysema or chronic bronchitis (NIGHT only)• persistent or chronic cough such 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
• taking the blood thinning drug warfarin• taking sedatives or tranquilizers (NIGHT only)
When Using These Products
• do not use more than directed• excitability may occur, especially in children (NIGHT only)• marked drowsiness may occur (NIGHT only)• alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)• avoid alcoholic drinks (NIGHT only)• be careful when driving a motor vehicle or operating machinery (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 headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
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 more than 10 caplets in any 24-hour period• adults and children 12 years of age and older: take 2 caplets every 4 hours• children under 12 years of age: do not use
Other Information
• each caplet contains: sodium 4 mg (DAY only)• store at 20-25°C (68-77°F)
Inactive Ingredients (Day Only)
croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Inactive Ingredients (Night Only)
crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Questions Or Comments?
1-800-719-9260
Principal Display Panel
Convenience Pack
Maximum Strength
For Ages 12+
Compare to active ingredients in Mucinex® Sinus-Max®
Sinus Relief
Pain Reliever – Acetaminophen
Expectorant – Guaifenesin
Nasal Decongestant – Phenylephrine HCl
DAY TIME
Relieves:
Sinus Pressure
Headache
Congestion
Thins & Loosens Mucus
Actual Size
10 CAPLETS
Pain Reliever – Acetaminophen
Antihistamine/Cough Suppressant – Diphenhydramine HCl
Nasal Decongestant – Phenylephrine HCl
NIGHT TIME
Relieves:
Nasal Congestion
Sinus Pressure & Pain
Runny Nose
Sneezing & Cough
Actual Size
10 CAPLETS
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