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Suphedrine PE by Wal-Mart Stores Inc

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-502

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.

Equate 44-502

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Nasal decongestant 

Uses
  • temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: 
    • minor aches and pains
    • nasal congestion 
    • headache
    • sinus congestion and pressure
  • promotes sinus drainage
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

  • skin reddening
  • blisters
  • rash

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

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 (1-800-222-1222) 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
  • do not use more than directed
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silica gel, stearic acid

Questions or comments?

1-888-287-1915

Principal Display Panel

NDC 49035-502-08

equate™

Compare to Sudafed PE® Pressure + Pain Active Ingredients*

Pressure & Pain
Suphedrine PE
Acetaminophen
and Phenylephrine HCl
Pain Reliever, Fever Reducer, Nasal Decongestant

Non-Drowsy

Relieves:
• Sinus pressure & congestion
• Sinus headache & pain

Maximum Strength

24
CAPLETS

Actual Size

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

DISTRIBUTED BY: Wal-Mart Stores, Inc.,
Bentonville, AR 72716 

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Pressure + Pain.
50844        REV0915B50208

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

Equate 44-502

SUPHEDRINE PE 
acetaminophen and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-502
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 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
POVIDONE 
STEARIC ACID 
STARCH, CORN 
CROSPOVIDONE 
MICROCRYSTALLINE CELLULOSE 
SILICON DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize18mm
FlavorImprint Code44;502
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-502-082 BLISTER PACK in 1 CARTON
112 TABLET in 1 BLISTER PACK
2NDC:49035-502-4212 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/23/2005
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(49035-502)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(49035-502)

 
Wal-Mart Stores Inc

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Medically reviewed on Jul 25, 2018

Further information

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

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