Sinus Relief

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Sinus Relief Recall

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Side Effects & Adverse Reactions

Liver warning: These products contain acetaminophen. The maximum daily dose of these products 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 these products • 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 RELIEF 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. • to make a child sleepy (SINUS RELIEF Night only) • if you have ever had an allergic reaction to these products or any of their ingredients • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to an enlarged prostate gland • glaucoma (SINUS RELIEF Night only) • a breathing problem such as emphysema or chronic bronchitis (SINUS RELIEF Night only) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (SINUS RELIEF Day only) • cough that occurs with too much phlegm (mucus) (SINUS RELIEF Day only) • taking the blood thinning drug warfarin • taking sedatives or tranquilizers (SINUS RELIEF Night only) • nervousness, dizziness, or sleeplessness occur • pain, cough 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 • cough comes back or occurs with rash or persistent headache.

These could be signs of a serious condition. (SINUS RELIEF Day only)

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

• temporarily relieves: • nasal congestion • headache • minor aches and pains • sinus congestion and pressure • runny nose and sneezing (SINUS RELIEF 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 (SINUS RELIEF Day only)

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History

There is currently no drug history available for this drug.

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Other Information

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Sources

Sinus Relief Manufacturers

Kroger Company

Sinus Relief | Kroger Company

• 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 and older: take 2 caplets every 4 hours • children under 12 years of age: do not use

No Recall
Kroger Company

Sinus Relief | Kroger Company

• 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 and older: take 2 caplets every 4 hours • children under 12 years of age: do not use

No Recall
Kroger Company

Sinus Relief | Kroger Company

• 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 and older: take 2 caplets every 4 hours • children under 12 years of age: do not use

No Recall
Chain Drug Marketing Association

Sinus Relief | Chain Drug Marketing Association

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

No Recall
Western Family Foods Inc

Sinus Relief | Western Family Foods Inc

Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply.
adults and children 6 yrs and older (with adult supervision) 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in 24 hours. children 2 to under 6 yrs ask a doctor children under 2 yrs do not use Other information store at 20°-25°C (68°-77°F)

No Recall
Hyvee Inc

Sinus Relief | Hyvee Inc

Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply.
adults and children 6 yrs and older (with adult supervision) 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in 24 hours. children 2 to under 6 yrs ask a doctor children under 2 yrs do not use Other information store at 20°-25°C (68°-77°F)

No Recall
King Bio Inc

Sinus Relief | King Bio Inc

Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth.

Adult dose: 3 pump sprays 3 times per day. Use additionally as needed.

Children 2-12 years: 2 pump sprays 3 times per day. Use additionally as needed.

Reference image sinus.jpg

No Recall
Meijer Distribution Inc

Sinus Relief | Meijer Distribution Inc

Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply.
adults and children 6 yrs and older (with adult supervision) 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in 24 hours. children 2 to under 6 yrs ask a doctor children under 2 yrs do not use Other information store at 20°-25°C (68°-77°F)

No Recall
Western Family Foods Inc

Sinus Relief | Western Family Foods Inc

do not take more than directed (see Liver warning) do not take the Day and Night caplets at the same time do not take more than a total of 12 caplets in 24 hours adults and children 12 years and over take 2 caplets every 4-6 hours swallow whole – do not crush, chew or dissolve children under 12 years do not use this adult product in children under 12 years of age do not take more than directed (see Liver warning) do not take the Day and Night caplets at the same time do not take more than a total of 12 caplets in 24 hours adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew or dissolve children under 12 years
do not use this adult product in children
under 12 years of age

No Recall
Homeocare Laboratories

Sinus Relief | Homeocare Laboratories

Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

No Recall
Western Family Foods Inc

Sinus Relief | Western Family Foods Inc

• do not take more than directed (see Liver warning) • do not take the Day and Night caplets at the same time • do not take more than a total of 10 caplets in 24 hours
DAYTIME

adults and children 12 years and over
• take 2 caplets every 4 hours • swallow whole – do not crush, chew or dissolve
children under 12 years

ask a doctor

NIGHTTIME

adults and children 12 years and over
• take 2 caplets every 4-6 hours • swallow whole – do not crush, chew or dissolve
children under 12 years

ask a doctor

No Recall
Similasan Corporation

Sinus Relief | Similasan Corporation

For adults and children ages 2 and over:
Remove tamper-evident plastic seal from bottle. Lift cap off bottle. Spray 1-3 times into each nostril. Use as needed. Replace cap after use.

No Recall
King Bio Inc.

Sinus Relief | King Bio Inc.

Directions:
Initially, depress pump until primed. Spray one dose directly into mouth. Adults: 3 sprays 3 times per day. Children (2-12 years): 2 sprays 3 times per day. Children (1 month-2 years): 1 spray 3 times per day.

No Recall
Homeolab Usa Inc.

Sinus Relief | Homeolab Usa Inc.

Adults: Allow 3 or 4 pellets to dissolve in mouth three times a day.

Children under 12: Take 1/2 the adult dose.

No Recall
New Sun Inc.

Sinus Relief | New Sun Inc.

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

Adult Dose: 3 Pump Sprays

Child's Dose (2-12): 2 Pump Sprays

Infants - 2 yrs: 1 Pump Spray

No Recall
Pharmwest Inc.

Sinus Relief | Pharmwest Inc.

Directions: Spray directly into mouth. Adult dose- 3 pump sprays 3 times daily. Children's Dose, (ages 2-12) 3 pump sprays, 3 times daily. Use additionally as needed.

No Recall