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Suphedrine PE by Target Corporation

Medically reviewed on Aug 23, 2018

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Target Corporation
NDC Code: 11673-526

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.

Target 44-526-Delisted

Active ingredients (in each caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses
  • temporarily relieves these symptoms of the common cold:
    • runny nose
    • sneezing
    • headache
    • minor aches and pains
    • nasal congestion
    • cough
    • sore throat
  • temporarily reduces fever 

Warnings

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

  • adults take more than 12 caplets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks ever day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, naussea, or vomitting, consult a doctor promptly.

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
  • with any other product containing diphenhydramine, even one used on skin
  • 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 the user has
  •  liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a cough accompanied by too much phlegm (mucus)

Ask a doctor or pharmacist before use if the user is
  • 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
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery 

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • pain, cough or nasal congestion gets worse or lasts more than 5 days (children) 7 days (adults)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts

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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.

Directions
  • do not use more than directed (see overdose warning)
adults and children 12 years and over 

take 2 caplets every 4 hours 

do not take more than 12 caplets in 24 hours

children 6 to under 12 years of age 

take one caplet every 4 hours

do not take more than 5 caplets in 24 hours 

children under 6 years of age do not use this product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage 

Other information
  • see end flap for expiration date and lot number
  • store at controlled room temperature 15º-30ºC (59º-86ºF) 

Inactive ingredients

 corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide

Principal Display Panel

NDC 11673-526-08

PE multi-symptom severe cold relief

acetaminophen, 325 mg

diphenhydramine HCl, 12.5 mg

phenylephrine HCl, 5 mg

Compare to the active ingredients in Sudafed PE®  Multi-Symptom Severe Cold Coated Caplets*

see new warnings information

relieves fever and body aches, cough and sore throat, nasal/sinus congestion

does not contain pseudoephedrine

up & up

24 COATED CAPLETS SHOWN ACTUAL SIZE

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE®  Multi-Symptom Severe Cold.

50844        REV0910A52608

094    03    0332    ID201455

Dist. by Target Corp., Mpls., MN 55403

©2011 Target Brands, Inc.

All Rights Reserved    Shop Target.com

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

Target 44-526

SUPHEDRINE PE 
acetaminophen, diphenhydramine hcl and phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-526
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code44;526
Contains    
Packaging
#Item CodePackage Description
1NDC:11673-526-081 BLISTER PACK in 1 CARTON
124 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/21/200511/04/2018
Labeler - Target Corporation (006961700)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(11673-526)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(11673-526)

 
Target Corporation

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Further information

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

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