SINUS CONGESTION AND PAIN DAYTIME- acetaminophen and phenylephrine hcl tablet 
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 44-558-Delisted

Active ingredients (in each gelcap)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Nasal decongestant

Uses

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.       

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

Ask a doctor before use if you have

  • heart disease
  • diabetes
  • liver disease
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure

Ask a doctor or pharmacist before use if you are

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
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

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 right away. Prompt 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

corn starch, croscarmellose sodium, crospovidone, 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, propylene glycol, shellac glaze, silicon dioxide, stearic acid, titanium dioxide

Questions or comments?

1-888-287-1915

Principal Display Panel

NDC 49035-558-22

equate™

Compare to
Tylenol® SINUS
+ HEADACHE
Day Active
Ingredients*

Rapid Release
Sinus
Congestion
& Pain

Acetaminophen, Phenylephrine HCl
Pain Reliever, Fever Reducer, Nasal Decongestant

Daytime Non-Drowsy

• Sinus headache & pressure
• Nasal congestion

48 GELCAPS

Actual Size

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

Satisfaction guaranteed - 
Or we'll replace it or give you your
money back.
For questions or comments,
please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

*This product is not manufactured or
distributed by Johnson & Johnson Corporation,
owner of the registered trademark Tylenol®
SINUS + HEADACHE Day.
50844          REV0418D55822


Equate 44-558

Equate 44-558

SINUS CONGESTION AND PAIN  DAYTIME
acetaminophen and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-558
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
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
STARCH, CORN (UNII: O8232NY3SJ)  
SHELLAC (UNII: 46N107B71O)  
Product Characteristics
Colorred (red, green and gray in the middle) , greenScoreno score
ShapeOVALSize19mm
FlavorImprint Code L;8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-558-224 in 1 CARTON03/17/200812/31/2025
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:49035-558-4212 in 1 BLISTER PACK; Type 0: Not a Combination Product03/17/200812/31/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/17/200812/31/2025
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(49035-558)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(49035-558)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(49035-558)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(49035-558)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(49035-558)

Revised: 9/2023
Document Id: 4ab4314e-ac81-4c34-a368-36582f53e360
Set id: 2746d0ad-7e3e-4d6b-a828-246050c2e06c
Version: 14
Effective Time: 20230925
 
Wal-Mart Stores Inc