COLD MULTI-SYMPTOM NIGHTTIME- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet

Cold Multi-Symptom by

Drug Labeling and Warnings

Cold 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 gelcap)

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/flu symptoms:
  • sore throat
  • headache
  • nasal congestion
  • cough
  • sinus congestion and pressure
  • sneezing and runny rose
  • minor aches and pains
• temporarily reduces fever
• helps clear nasal passages
• relieves cough to help you sleep

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 gelcaps (3,250 mg acetaminophen). Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours
• 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• glaucoma
• diabetes
• liver disease
• heart disease
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• high blood pressure
• thyroid disease
• persistent or chronic cough 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
• taking sedatives or tranquilizers

When using this product

• do not exceed recommended dosage
• avoid alcoholic drinks
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• excitability may occur, especially in children
• 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
• new symptoms occur
• fever gets worse or lasts more than 3 days
• persistent cough lasts for more than one week, tends to recur, or accompanied by fever, rash, or persistent headache
• redness or swelling is present

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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  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 overdose warning)
• adults and children 12 years and over
  • take 2 gelcaps every 4 hours
  • do not take more than 10 gelcaps in 24 hours
  • swallow whole; do not crush, chew or dissolve
• children under 12 years: ask a doctor

Other information

• avoid high humidity
• see end flap for expiration date and lot number
• store at 25ºC (77ºF); excursions permitted between 15º-30º C (59º-86ºF)

Inactive ingredients

ammonium hydroxide, black iron oxide, croscarmellose sodium, crospovidone, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, red iron oxide, shellac glaze, silica gel, simethicone, stearic acid, titanium dioxide, yellow iron oxide

Questions or comments?

1-800-426-9391

Principal Display Panel

KIRKLAND Signature™

COMPARE TO TYLENOL®
COLD MULTI-SYMPTOM
NIGHTTIME
active ingredients*

NDC: 63981-591-22
ITM. / ART.
719938

NIGHTTIME 

COLD
MULTI-SYMPTOM

Acetaminophen 325 mg, Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

Pain Reliever/Fever Reducer, Nasal Decongestant,

Cough Suppressant, Antihistamine

Temporarily Relieves:

• Fever/Headache/Sore Throat
• Nasal Congestion
• Coughing
• Runny nose

Actual Size

48 Rapid Release
Gelcaps

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Multi-Symptom Nighttime.

50844 REV1213B59122
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
13V1092c

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

Kirkland 44-591

INGREDIENTS AND APPEARANCE

COLD MULTI-SYMPTOM  NIGHTTIME
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63981-591
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (dark)	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	L;A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63981-591-22	4 in 1 CARTON	03/29/2008	11/28/2020
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	03/29/2008	11/28/2020

Labeler - COSTCO WHOLESALE CORPORATION (103391843)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(63981-591)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(63981-591)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(63981-591)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(63981-591)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(63981-591)