COLD AND FLU MULTI-SYMPTOM DAYTIME/NIGHTTIME SEVERE- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, guaifenesin and phenylephrine hcl kit

Cold and Flu Multi-Symptom by

Drug Labeling and Warnings

Cold and Flu Multi-Symptom by is a Otc medication manufactured, distributed, or labeled by COSTCO WHOLESALE CORPORATION, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)(Daytime Cold & Flu Severe)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain  reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Active ingredients (in each caplet)(Nighttime Cold & Flu Severe)

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
  • headache
  • sore throat
  • minor aches and pains
  • nasal congestion
  • sinus congestion and pressure (Nighttime only)
  • sneezing and runny nose (Nighttime only)
• help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (Daytime only)
• helps clear nasal passages (Nighttime only)
• relieves cough to help you sleep (Nighttime only)
• temporarily reduces fever

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours
• 3 or more alcoholic drinks every day while using this product
• with other drugs containing acetaminophen

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)
• high blood pressure
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)
• 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)
• use caution 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
• new symptoms 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
• 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.

Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

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

• see end flap for expiration date and lot number
• 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)

Inactive ingredients (Daytime only)

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

Questions or comments?

 1-800-426-9391

Principal display panel

• KIRKLAND Signature COMPARE TO TYLENOL®COLD + FLU SEVERE DAYactive ingredients* Non-Drowsy DAYTIME SEVERE COLD & FLUMULTI-SYMPTOM Acetaminophen 325 mg,Dextromethorphan HBr 10 mg,Guaifenesin 200 mg, Phenylephrine HCl 5 mg Pain reliever Fever Reducer Cough SuppressantExpectorant Nasal Decongestant Relieves:Head and Body AchesFever and Sore ThroatNasal CongestionCoughMucus and Chest Congestion Actual Size 2 x 60 CAPLETS:

  KIRKLAND NDC: 63981-702-81 ; Signature

  COMPARE TO TYLENOL®; COLD + FLU SEVERE NIGHT; active ingredients* ;

  NIGHTTIME SEVERE ; COLD & FLU; MULTI-SYMPTOM

  Acetaminophen 325 mg,; Chlorpheniramine Maleate 2 mg,; Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

  Pain reliever Fever Reducer Antihistamine; Cough Suppressant Nasal Decongestant

  Relieves:; Head and Body Aches; Fever and Sore Throat; Nasal Congestion; Cough; Runny Nose;

  Actual Size;

  48 ; CAPLETS

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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® COLD + FLU  SEVERE Day & Tylenol® COLD + FLU SEVERE Night.

50844 REV0718B50347381

This product does not contain gluten.

Manufactured by:
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA

For: Costco Wholesale Corporation
P.O. Box 34535
Seattle, WA 98124-1535 USA
1-800-774-2678
www.costco.com
16V1012a

Kirkland 44-503A473

INGREDIENTS AND APPEARANCE

COLD AND FLU MULTI-SYMPTOM  DAYTIME/NIGHTTIME SEVERE
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, guaifenesin and phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63981-702

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63981-702-81	1 in 1 CARTON; Type 0: Not a Combination Product	08/04/2005

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	10 BLISTER PACK	120
Part 2	4 BLISTER PACK	48

Part 1 of 2

COLD AND FLU MULTI-SYMPTOM  DAYTIME SEVERE
acetaminophen, dextromethorphan hbr, guaifenesin and phenylephrine hcl tablet, film coated

Product Information
Item Code (Source)	NDC: 63981-503
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;503
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63981-503-11	5 in 1 BOX
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/04/2005

Part 2 of 2

COLD AND FLU MULTI-SYMPTOM  NIGHTTIME SEVERE
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hcl tablet, film coated

Product Information
Item Code (Source)	NDC: 63981-473
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
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63981-473-22	4 in 1 BOX
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/04/2005

Labeler - COSTCO WHOLESALE CORPORATION (103391843)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(63981-702, 63981-503, 63981-473)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(63981-702, 63981-503, 63981-473)