RAPID RELEASE MULTI-SYMPTOM ALLERGY RELIEF- acetaminophen, phenylephrine hcl, chlorpheniramine maleate capsule, gelatin coated 
Wal-Mart Stores Inc

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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Equate 44-559 Delisted

Active ingredients (in each gelcap)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylepherine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant 

Uses

Warnings

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

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 taking 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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • drowsiness may occur

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • 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

Other information

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?

1-888-287-1915

Principal display panel

NDC 49035-559-08

equate®

Compare to Tylenol® Allergy Multi-Symptom Active Ingredients*

Rapid Release
Multi-Symptom
Allergy Relief
Pain reliever, Nasal decongestant, Antihistamine

Contains 3 medicines
• Headache - Acetaminophen
• Sinus pressure/Nasal Congestion - Phenylephrine HCl
• Runny nose/Sneezing
   Itchy, Watery eyes - Chlorpheniramine maleate

Pseudoephedrine Free

24
GELCAPS

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716 
©Wal-Mart Stores, Inc.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Allergy Multi-Symptom.
50844        REV0812A55908

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

Equate 44-559

Equate 44-559

RAPID RELEASE MULTI-SYMPTOM ALLERGY RELIEF 
acetaminophen, phenylephrine hcl, chlorpheniramine maleate capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-559
Route of AdministrationORAL
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 (red with grey band) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code L;9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-559-081 in 1 CARTON
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/17/2008
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(49035-559)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(49035-559)

Revised: 10/2015
Document Id: 5bb7babd-c700-4c2d-93f8-66ae69b03e76
Set id: 7fc09c01-a822-4b8b-a967-dcc7048d226c
Version: 3
Effective Time: 20151016
 
Wal-Mart Stores Inc