COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl 
Kroger Company

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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Kroger Co. Cold Drug Facts

Active ingredient (in each caplet) (Nighttime)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose (Nighttime)

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses (Nighttime)

temporarily relieves these common cold symptoms:
minor aches and pains
headache
sore throat
nasal congestion
cough
sneezing and runny nose
helps clear nasal passages
relieves cough to help you sleep
temporarily reduces fever

Warnings (Nighttime)

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 this product

do not exceed recommended dosage
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 (Nighttime)

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

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 (Nighttime)

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

Questions or comments? (Nighttime)

1-800-632-6900

Active ingredient (in each caplet) (Daytime)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose (Daytime)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses (Daytime)

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

Warnings (Daytime)

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
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)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

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 (Daytime)

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

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

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

Questions or comments? (Daytime)

1-800-632-6900

Principal Display Panel

COOL ICE®

INSTANT COOLING SENSATION

COMPARE TO active ingredients of TYLENOL® COLD MULTI-SYMPTOM DAY & NIGHT CAPLETS

See end panel

DAY / NIGHT COMBO PACK

Cold

SEE NEW WARNINGS INFORMATION

Multi-Symptom

Pain Reliever/Fever Reducer/Nasal Decongestant/Cough Suppressant/*Antihistamine

Save when you buy DayTime and Night Time

NON-DROWSY

DAYTIME

Pain Reliever/Fever Reducer/Nasal Decongestant/Cough Suppressant

Acetaminophen/Dextromethorphan HBr/Phenylephrine HCl

Fever/Headache/Sore Throat

Nasal Congestion

Coughing

NIGHT TIME

Pain Reliever/Fever Reducer/Nasal Decongestant/Cough Suppressant/*Antihistamine

Acetaminophen/Chlorpheniramine Maleate/Dextromethorphan HBr/Phenylephrine HCl

Fever/Headache/Sore Throat

Nasal Congestion

Coughing

Runny Nose

*Antihistamine in Nighttime Only

Cold Carton Image 1

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COLD 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-250
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-250-041 in 1 CARTON; Type 0: Not a Combination Product09/08/200707/16/2012
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 BLISTER PACK 12 
Part 1 of 2
NIGHT TIME 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeCAPSULESize17mm
FlavorVANILLA (menthol) Imprint Code L393
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 KIT
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/08/2007
Part 2 of 2
DAYTIME 
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize16mm
FlavorVANILLA (menthol) Imprint Code L402
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 KIT
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/08/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/08/200707/16/2012
Labeler - Kroger Company (006999528)

Revised: 2/2019
 
Kroger Company