Severe Cold Relief

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Target Corporation
NDC Code: 11673-503

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 44-503c

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestion

Uses
  • temporarily relieves these common cold/flu symptoms:

    • headache

    • minor aches and pains

    • sore throat

    • nasal congestion

    • cough

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs  more productive

  • temporarily reduces fever

Warnings

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

  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, 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.

  • 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
  • liver disease

  • diabetes

  • heart disease

  • high blood pressure

  • thyroid disease

  • trouble urinating due to an enlarged prostate gland

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • cough that occurs with too much phlegm (mucus)

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, nasal congestion, or cough gets worse or lasts more than 7 days

  • new symptoms occur

  • fever gets worse or lasts more than 3 days

  • redness or swelling is present

  • 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 or symptoms.

Directions
  • do not take more than directed (see overdose warning)

  • adults and children 12 years and over

    • take 2 caplets every 4 hours

    • swallow whole - do not crush, chew, or dissolve

    • do not take more than 12 caplets in 24 hours

  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information
  • store at controlled room temperature 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Principal Display Panel

NDC 11673-503-08

severe cold relief

non-drowsy

acetaminophen, 325 mg

dextromethorphan HBr, 10 mg

guaifenesin, 200 mg

phenylephrine HCl, 5 mg

Compare to active ingredients

in Tylenol® Cold Multi-Symptom

Severe Daytime Caplets

pain reliever, fever reducer, nasal decongestant, cough suppressant, expectorant

for ages 12 and older, with cool-blast sensation

up to 4 hours relief

does not contain pseudoephedrine

up & up

DAY

24 CAPLETS

24 CAPLETS SHOWN ACTUAL SIZE ABOVE

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

50844        REV0111B50308

094 14 0202 ID201455

Distributed by Target Corporation, Mpls., MN 55403

© 2012 Target Brands, Inc.

All Rights Reserved   Shop Target.com

Target 44-503C

SEVERE COLD RELIEF 
acetaminophen, dextromethorphan hbr, phenylephrine hcl and guaifenesin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-503
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCRALOSE 
TITANIUM DIOXIDE 
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize19mm
FlavorMENTHOLImprint Code44;503
Contains    
Packaging
#Item CodePackage Description
1NDC:11673-503-081 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
124 TABLET, FILM COATED (24 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/22/2006
Labeler - Target Corporation (006961700)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(11673-503)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(11673-503)

Revised: 08/2012
 
Target Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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