UP AND UP COLD RELIEF- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit

up and up cold relief by

Drug Labeling and Warnings

up and up cold relief by is a Otc medication manufactured, distributed, or labeled by Target Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

UP AND UP COLD RELIEF 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-250

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-250-56	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	8
Part 2	1 BLISTER PACK	12

Part 1 of 2

NIGHT 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONES (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (light blue)	Score	no score
Shape	CAPSULE	Size	17mm
Flavor	VANILLA (menthol)	Imprint Code	L393
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/31/2009

Part 2 of 2

DAY 
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONES (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	16mm
Flavor	VANILLA (menthol)	Imprint Code	L402
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		12 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/31/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/31/2009

Labeler - Target Corporation (006961700)