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NDC 00363-0529-08 Cold Details

Cold

Cold is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is .

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 00363-0529-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 00363-0529-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 00363-0529-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 00363-0529-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	00363-0529
Product ID	0363-0529_4762e733-3295-4222-a825-2a39fe922b23
Associated GPIs	43995904166320
GCN Sequence Number	060988
GCN Sequence Number Description	DM/pe/acetaminophen/chlorphenr TABLET SEQ 10-5-325-2 ORAL
HIC3	B3P
HIC3 Description	NON-OPIOID ANTITUS-1STGEN ANTIHIST-DECON-ANALGESIC
GCN	27143
HICL Sequence Number	000372
HICL Sequence Number Description	DEXTROMETHORPHAN/PHENYLEPHRINE/ACETAMINOPHEN/CHLORPHENIRAMIN
Brand/Generic	Generic
Proprietary Name	Cold
Proprietary Name Suffix	MULTI-SYMPTOM, DAYTIME / NIGHTTIME
Non-Proprietary Name	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Walgreen Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00363-0529-08 (00363052908)

Pricing Information	N/A
NDC Package Code	0363-0529-08
Billing NDC	00363052908
Package	1 KIT in 1 CARTON (0363-0529-08) * 12 TABLET, FILM COATED in 1 BLISTER PACK * 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2005-07-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f50f505f-9eca-4e67-97ef-34db98844ff5 Details

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

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:
- cough
- sore throat
- headache
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- sneezing and runny nose (Nighttime only)
helps clear nasal passages
relieves cough to help you sleep (Nighttime only)
promotes nasal and sinus drainage (Daytime only)
temporarily reduces fever

Warnings

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

with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
more than 4,000 mg in 24 hours, which is the maximum daily amount

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease
diabetes
thyroid disease
heart disease
glaucoma (Nighttime only)
cough that occurs with too much phlegm (mucus)
high blood pressure
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis (Nighttime only)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers (Nighttime only)

When using this product

do not exceed recommended dosage
excitability may occur, especially in children (Nighttime only)
marked drowsiness may occur (Nighttime only)
avoid alcoholic beverages (Nighttime only)
be careful when driving a motor vehicle or operating machinery (Nighttime only)
alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

if taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.

Directions

do not take more than directed
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 10 caplets in 24 hours
children under 12 years: ask a doctor

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients (Daytime only)

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

Inactive ingredients (Nighttime only)

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

DAY & NIGHT PACK

NDC 0363-0529-08

Walgreens

Compare to Tylenol® Cold Max

Day & Tylenol® Cold Multi-Symptom

Night active ingredients††

DAYTIME • NON-DROWSY Cold ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT PHENYLEPHRINE HCl / NASAL DECONGESTANT	NIGHTTIME Cold ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER CHLORPHENIRAMINE MALEATE / ANTIHISTAMINE DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT PHENYLEPHRINE HCl / NASAL DECONGESTANT
MULTI-SYMPTOM • Relieves fever, headache, sore throat, cough & nasal congestion 12 CAPLETS Actual Size	MULTI-SYMPTOM • Relieves fever, headache, sore throat, cough & nasal congestion 12 CAPLETS Actual Size

24 TOTAL CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY

SIGNS OF TAMPERING

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

††This product is not manufactured or distributed by McNeil Consumer

Healthcare, owner of the registered trademark Tylenol® Cold Max

Day & Tylenol® Cold Multi-Symptom Night.

50844 ORG031647047308

DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED walgreens.com ©2017 Walgreen Co.

Walgreens 44-470C47308CH

INGREDIENTS AND APPEARANCE

COLD MULTI-SYMPTOM, DAYTIME / NIGHTTIME

acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0529

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0529-08	1 in 1 CARTON; Type 0: Not a Combination Product	07/21/2005

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

Part 1 of 2
COLD MULTI-SYMPTOM/DAYTIME acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor	MINT	Imprint Code	44;470
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/15/2005

Part 2 of 2
COLD MULTI SYMPTOM/NIGHTTIME acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	17mm
Flavor	MINT	Imprint Code	44;473
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/21/2005

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/21/2005

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(0363-0529) , pack(0363-0529)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-0529)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(0363-0529)

Revised: 9/2022

Document Id: 4762e733-3295-4222-a825-2a39fe922b23

Set id: f50f505f-9eca-4e67-97ef-34db98844ff5

Version: 15

Effective Time: 20220907

Search by Drug Name or NDC

NDC 00363-0529-08 Cold Details

Cold

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00363-0529-08 (00363052908)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f50f505f-9eca-4e67-97ef-34db98844ff5 Details

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

Purpose

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

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients (Daytime only)

Inactive ingredients (Nighttime only)

Questions or comments?

Principal Display Panel

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