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

Medically reviewed on September 27, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: L&R Distributors, Inc.
NDC Code: 15127-966

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 44-455C-SC

Active ingredients (in each caplet)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant 

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 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
  • 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: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage 

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-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 

Questions or comments?

1-800-426-9391 

Principal Display Panel

NDC 15127-966-24

select brand®
the lower price name brand

DOES NOT CONTAIN PSEUDOEPHEDRINE

Sinus
Congestion & Pain

Acetaminophen - Pain Reliever
Chlorpheniramine maleate - Antihistamine
Phenylephrine HCl - Nasal Decongestant

Headache, Sinus Pressure, Nasal Congestion, Runny Nose

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

24 COOL CAPLETS

actual size

Nighttime 

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Sinus Congestion & Pain Nighttime.
50844     REV0612C45508

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

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

SATISFACTION
select brand®
GUARANTEED

Select Brand 44-455C

SINUS CONGESTION AND PAIN 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-966
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
STARCH, CORN 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
SILICON DIOXIDE 
CROSPOVIDONE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorMINTImprint Code44;455
Contains    
Packaging
#Item CodePackage Description
1NDC:15127-966-242 BLISTER PACK in 1 CARTON
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
Labeler - L&R Distributors, Inc. (012578514)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(15127-966)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(15127-966)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(15127-966)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(15127-966)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(15127-966)

 
L&R Distributors, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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