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Sinus Congestion and Pain by L&R Distributors, Inc.

Medically reviewed on September 18, 2017

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: L&R Distributors, Inc.
NDC Code: 15127-933

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Select Brand 44-455C466

Active ingredients (in each caplet) (Daytime Sinus Congestion & Pain)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Nasal decongestant

Active ingredients (in each caplet) (Nighttime Sinus Congestion & Pain)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Uses
  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • nasal congestion
    • minor aches and pains
    • headache
    • sinus congestion and pressure
    • runny nose and sneezing (Nighttime only)
  • promotes sinus drainage
  • helps clear nasal passages
  • helps decongest sinus openings and passages
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • 3 or more alcoholic drinks every day while using this product
  • with other drugs containing acetaminophen

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
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • 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.

Ask a doctor before use if you have
  • heart disease
  • high blood pressure
  • liver disease
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • glaucoma (Nighttime only)

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product
  • do not exceed recommended dosage
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)
  • may cause drowsiness (Nighttime only)
  • excitability may occur, especially in children (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.

Directions
  • do not take more than directed
  • 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 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients (Daytime only)

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, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Inactive ingredients (Nighttime only)

corn starch, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica 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

Acetaminophen -
Pain Reliever/Fever Reducer
Phenylephrine HCl -
Nasal Decongestant
Relieves
Sinus Headache and Pressure,
Nasal Congestion


Daytime
Non-Drowsy

Acetaminophen -
Pain Reliever/Fever Reducer
Chlorpheniramine maleate -
Antihistamine
Phenylephrine HCl -
Nasal Decongestant
Relieves
Fever Headache, Sinus Pressure,
Nasal Congestion, Runny Nose

Nighttime

*Compare to the Active Ingredients of Tylenol® SINUS + HEADACHE and  Congestion & Pain Daytime and Nighttime

12 COOL CAPLETS                                        12 COOL CAPLETS
with Cool Blast Flavor                                    with Cool Blast Flavor

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

*This product is not manufactured or distributed by
McNeil Consumer Healthcare, owner of the registered
trademark Tylenol® SINUS + HEADACHE Day and
Tylenol® Sinus Congestion & Pain Night.
50844                REV0716D45546608

SATISFACTION select brand® GUARANTEED

Distributed by:
SELECT BRAND® DISTRIBUTORS
Pine Blu, AR 71603 USA
AC (870) 535-3635

Select Brand 44-455C466

SINUS CONGESTION AND PAIN 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-933
Packaging
#Item CodePackage Description
1NDC:15127-933-241 KIT in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 BLISTER PACK 12 
Part 1 of 2
SINUS CONGESTION AND PAIN  DAYTIME
acetaminophen, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
TITANIUM DIOXIDE 
CROSPOVIDONE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
STEARIC ACID 
SUCRALOSE 
TALC 
FD&C RED NO. 40 
POLYVINYL ALCOHOL, UNSPECIFIED 
SILICON DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize17mm
FlavorMINTImprint Code44;466
Contains    
Packaging
#Item CodePackage Description
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/26/2005
Part 2 of 2
SINUS CONGESTION AND PAIN  NIGHTTIME
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CROSPOVIDONE, UNSPECIFIED 
STARCH, CORN 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
POLYVINYL ALCOHOL, UNSPECIFIED 
SILICON DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorMINTImprint Code44;455
Contains    
Packaging
#Item CodePackage Description
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/28/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/26/2005
Labeler - L&R Distributors, Inc. (012578514)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(15127-933)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(15127-933)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(15127-933)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(15127-933)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(15127-933)

 
L&R Distributors, Inc.

← See all Sinus Congestion and Pain brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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