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up and up cold relief

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Target Corporation
NDC Code: 11673-250

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 Corporation Cold Relief Drug Facts

Active ingredients (in each caplet) Cold Multi-Symptom Day

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients (in each caplet) Cold Multi-Symptom Night

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose (Day)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose (Night)

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses (Day)
temporarily relieves these common cold/flu symptoms:
minor aches and pains
headache
sore throat
nasal congestion
cough
sinus congestion and pressure
helps clear nasal passages
promotes nasal and sinus drainage
temporarily reduces fever

Uses (Night)
temporarily relieves these common cold/flu symptoms:
minor aches and pains
headache
sore throat
nasal congestion
cough
sneezing and runny nose
sinus congestion and pressure
helps clear nasal passages
relieves cough to help you sleep
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.
to make a child sleepy

Ask a doctor before use if you have
liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
glaucoma

Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using these products
do not exceed recommended dosage

In addition, when using Cold Multi-Symptom Night:

excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery

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
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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 Liver warning)
do not take the Day and Night caplets at the same time
do not take more than a total of 12 caplets in 24 hours

DAYTIME

adults and children 12 years and over

take 2 caplets every 4 hours
swallow whole – do not crush, chew or dissolve

children under 12 years

do not use this adult product in children under

12 years of age

NIGHTTIME

adults and children 12 years and over

take 2 caplets every 4-6 hours
swallow whole – do not crush, chew or dissolve

children under 12 years

do not use this adult product in children under

12 years of age

Inactive ingredients

DAYTIME acesulfame potassium, carnauba wax, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide

NIGHTTIME acesulfame potassium, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions?

Call 1-800-910-6874

Principal Display Panel

cold relief

multi-symptom

instant cooling sensation

day/night combo pack

pain reliever/fever reducer, nasal decongestant, cough suppressant, antihistamine*

see new warnings information

Compare to active ingredients in Tylenol® Cold Multi-Symptom Day

acetaminophen - fever/headache/sore throat

phenylephrine HCl - nasal congestion

dextromethorphan HBr - coughing

non-drowsy

does not contain pseudoephedrine

Compare to active ingredients in Tylenol® Cold Multi-Symptom Night

acetaminophen - fever/headache/sore throat

phenylephrine HCl - nasal congestion

dextromethorphan HBr - coughing

chlorpheniramine maleate - runny nose

does not contain pseudoephedrine

*antihistamine in nighttime only

DAY/NIGHT

20 COOL ICE® CAPLETS

12 DAY (TOP) AND 8 NIGHT (BOTTOM)

SHOWN ACTUAL SIZE ABOVE

UP AND UP COLD RELIEF 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-250
Packaging
#Item CodePackage Description
1NDC:11673-250-561 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 BLISTER PACK 12 
Part 1 of 2
NIGHT 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
WATER 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeCAPSULESize17mm
FlavorVANILLA (menthol) Imprint CodeL393
Contains    
Packaging
#Item CodePackage Description
18 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/2009
Part 2 of 2
DAY 
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CARNAUBA WAX 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize16mm
FlavorVANILLA (menthol) Imprint CodeL402
Contains    
Packaging
#Item CodePackage Description
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/2009
Labeler - Target Corporation (006961700)

Revised: 10/2012
 
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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