Wal-Mart Suphedrine PE Drug Facts

Wal-Mart Suphedrine PE Drug Facts

Drug Labeling and Warnings

Drug Details

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EQUATE SUPHEDRINE PE- phenylephrine hydrochloride 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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Wal-Mart Suphedrine PE Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Warnings

Do not use

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • diabetes

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

adults and children 12 years and over

  • take 1 tablet every 4 hours
  • do not take more than 6 tablets in 24 hours

children under 12 years

ask a doctor

Other information

  • store at 20-25ºC (68-77ºF)
  • do not use if blister unit is broken or torn

Inactive ingredients

anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

1-888-287-1915

Principal Display Panel

Compare to Sudafed PE® Congestion Active Ingredient

Congestion

Suphedrine PE

Phenylephrine HCl Tablets, 10 mg

Nasal Decongestant

Non-Drowsy

Relieves:

Sinus Pressure

Congestion

Maximum Strength

10 mg

24 TABLETS

Actual Size

Equate Suphedrine PE image
EQUATE SUPHEDRINE PE 
phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49035-131
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49035-131-8918 in 1 CARTON03/21/201403/14/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 49035-131-6836 in 1 CARTON03/21/201403/14/2018
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 49035-131-6224 in 1 CARTON07/19/2016
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/21/2014
Labeler - Wal-Mart Stores Inc (051957769)

Revised: 10/2016
 
Wal-Mart Stores Inc


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