Sinus Congestion and Pain description, usages, side effects, indications, overdosage, supplying and lots more!

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Sinus Congestion and Pain

Stephen L. LaFrance Pharmacy, Inc.

Select Brand 44-455C466


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Chlorpheneramine maleate 2 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant

Sinus Congestion and Pain Uses

  • for the temporary relief of:
    • sinus congestion and pressure
    • nasal congestion
    • runny nose and sneezing
    • headache
    • minor aches and pains
  • reduces swelling of nasal passages
  • helps decongest sinus openings and passages

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 every day while using this product

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 emotion 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
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • 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
  • 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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

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: 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. 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)
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew or dissolve
    • do not take more than 12 caplets in 24 hours
  • children under 12 years of age: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) any may cause liver damage.

Sinus Congestion and Pain Other information

  • store at controlled room temperature 15º to 30ºC (59º to 86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Active ingredient (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Nasal decongestant

Sinus Congestion and Pain Uses

  • for the temporary relief of:
    • headache
    • sinus congestion and pressure
    • minor aches and pains
    • nasal congestion
    • runny nose and sneezing
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages

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 every day while using this product

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 emotion 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
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

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: 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. 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)
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew or dissolve
    • do not take more than 12 caplets in 24 hours
  • children under 12 years of age: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) any may cause liver damage.

Sinus Congestion and Pain Other information

  • store at controlled room temperature 15º to 30ºC (59º to 86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, 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, silicia gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

select brand®
the lower price name brand

NDC 15127-933-24

Sinus
Congestion & Pain
Pain Reliever, Nasal Decongestant, Antihistamine**

Headache - Acetaminophen
Sinus Pressure Nasal Congestion - Phenylephrine HCl

Daytime
Non-Drowsy

Headache - Acetaminophen
Sinus Pressure Nasal Congestion - Phenylephrine HCl
Runny Nose - Chlorpheniramine maleate

Nighttime
**Antihistamine  in Nighttime Only

*Compare to the Active Ingredients of Tylenol® Sinus Congestion & Pain

12 COOL CAPLETS
with Cool Blast Flavor

*This product is not manufacture or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Sinus Congestion & Pain Daytime and Nighttime.
50844        REV0810.455/0310.46608

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING

Sinus Congestion and Pain
Select Brand 44-455C466

Sinus Congestion and Pain

Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:15127-933
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:15127-933-24 1 in 1 PACKAGE, COMBINATION

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2005-07-15


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