ALLERGY RELIEF- acetaminophen, phenylephrine hydrochloride and chlorpheniramine maleate capsule, gelatin coated 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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.

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CVS 44-559 Delisted

Active ingredients (in each gelcap)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant 

Uses

  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    • sinus congestion and pressure
    • nasal congestion
    • runny nose and sneezing
    • headache
    • minor aches and pains
  • temporarily relieves these additional symptoms of hay fever
    • itching of the nose or throat
    • itchy, watery eyes
  • helps clear 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 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 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
  • new symptoms occur
  • 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 (1-800-222-1222) 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 25ºC (77ºF); excursions permitted between 15º to 30ºC (59º-86ºF)
  • contains FD&C Yellow #5 (tartrazine) as a color additive
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C red #3, FD&C red #40, FD&C yellow #5, 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

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CVS®
pharmacy

Compare to the active ingredients in Tylenol® Allergy Multi-Symptom†

ALLERGY
RELIEF

MULTI-SYMPTOM
PAIN RELIEVER, NASAL DECONGESTANT, ANTIHISTAMINE

CONTAINS 3 MEDICINES
 Sinus pressure, nasal congestion - Phenylephrine HCl    
• Runny Nose / sneezing
• Itchy, watery eyes - Chlorpheniramine maleate
• Headache - Acetaminophen

24 GELCAPS 

TAMPER EVIDENT: DO NOT USE IF CARTON 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® Allergy Multi-Symptom.

50844    REV0812D55908

Distributed by: CVS/pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2012 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

V-18615
CVS 44-559

CVS 44-559

ALLERGY RELIEF 
acetaminophen, phenylephrine hcl, chlorpheniramine maleate capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-559
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColorYELLOW (with dark red) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code L;9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-559-071 in 1 CARTON
136 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:59779-559-082 in 1 CARTON
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/17/200812/05/2015
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-559)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(59779-559)

Revised: 10/2015
 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED