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Sinus Congestion and Pain Relief

Dosage form: capsule
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Rite Aid
NDC Code: 11822-0588

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.

Rite Aid 44-558

Active ingredients

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Nasal decongestant

Uses
  • for the temporary relief of:
    • headache
    • sinus congestion and pressure
    • minor aches and pains
    • nasal congestion
  • 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 gelcaps 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
  • 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
  • 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 of 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 gelcaps every 4 hours
  • do not take more than 12 gelcaps 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 controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

 croscarmellose sodium, croscpovidone, D&C yellow #10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide

Questions or comments?

 1-800-426-9391

Principal Display Panel

RITE AID®

PHARMACY

*Compare to the active ingredients in Tylenol® Sinus Congestion & Pain Daytime

sinus congestion & pain relief

acetaminophen 325 mg

phenylephrine HCl 5 mg

pain reliever & nasal decongestant

NON-DROWSY

DAYTIME

relieves:

headache

sinus pressure/nasal congestion

SEE NEW WARNINGS INFORMATION

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

50844      ORG120955808

DISTRIBUTED BY: RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

558-R

SINUS CONGESTION AND PAIN RELIEF 
acetaminophen and phenylephrine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0588
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
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorRED (green and grey) Scorescore with uneven pieces
ShapeCAPSULESize19mm
FlavorImprint Code44;558
Contains    
Packaging
#Item CodePackage Description
1NDC:11822-0588-71 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
130 CAPSULE (30 CAPSULE) in 1 BLISTER PACK
2NDC:11822-0588-81 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
224 CAPSULE (24 CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34303/17/2008
Labeler - Rite Aid (014578892)

Revised: 07/2012
 
Rite Aid

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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