MULTI-SYMPTOM COLD RELIEF DAYTIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Multi-Symptom Cold Relief by

Drug Labeling and Warnings

Multi-Symptom Cold Relief by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant 

Uses

• temporarily relieves these common cold/flu symptoms:
  • minor aches and pains
  • headache
  • nasal congestion
  • cough
  • sore throat
  • sinus congestion and pressure
• helps clear nasal passages
• promotes nasal and sinus drainage
• 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. 

Ask a doctor before use if you have

• liver disease
• diabetes
• heart disease
• high blood pressure
• thyroid disease
• trouble urinating due to an enlarged prostate gland
• 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

When using this product

• do not exceed recommended dosage 

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.

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 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 caplets every 4 hours
  • swallow whole - do not crush, chew, or dissolve
  • do not take more than 12 caplets in 24 hours
• children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause severe liver damage 

Other information

• store at controlled room temperature 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number 

Inactive ingredients

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

Questions or comments?

Call 1-800-426-9391 

Principal display panel

QUALITY PLUS

NDC: 50844-470-02

 *Compare to the active ingredients in Tylenol® Cold Multi-Symptom Daytime

DAYTIME

Multi-Symptom
Cold Relief

Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant

For Non-Drowsy Relief of:

Fever/Headache/Sore Throat - Acetaminophen

Nasal Congestion - Phenylephrine HCl

Coughing - Dextromethorphan HBr

12 Cool Caplets

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

Does not contain Pseudoephedrine

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

50844  ORG081047002

Distributed by LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788

USA

LNK 470

INGREDIENTS AND APPEARANCE

MULTI-SYMPTOM COLD RELIEF  DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-470
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
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	17mm
Flavor	MINT (Cool Blast)	Imprint Code	44;470
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50844-470-02	1 in 1 BOX	07/15/2005
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	07/15/2005

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(50844-470)