COLD, FLU AND SORE THROAT RELIEF MAXIMUM STRENGTH, MULTI SYMPTOM- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated

Cold, Flu and Sore Throat Relief by

Drug Labeling and Warnings

Cold, Flu and Sore Throat Relief by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

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

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • sore throat
  • headache
  • minor aches and pains
  • cough
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
  

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

• blisters
• rash
• skin reddening

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

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

• new symptoms occur
• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• redness or swelling is present
  
• fever gets worse or lasts more than 3 days
• 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.

Directions

• do not take more than directed
• do not take more than 12 caplets in any 24-hour period
• adults and children 12 years and over: take 2 caplets every 4 hours
• children under 12 years: do not use

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• use by expiration date on package
  

Inactive ingredients

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

Questions?

Call 1-800-824-1706 Monday - Friday 9am - 4pm MST

Principal Display Panel

WinCo®
FOODS

MAXIMUM STRENGTH
Cold, Flu &
Sore Throat Relief

Multi-Symptom

ACETAMINOPHEN/
PAIN RELIEVER - FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT

30
Caplets

Relieves Headache, Fever, Sore Throat,
Nasal & Chest Congestion. Controls
Cough, Thins & Loosens mucus

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

KEEP OUTER PACKAGE FOR
COMPLETE PRODUCT INFORMATION

DISTRIBUTED BY: WINCO FOODS, LLC
BOISE, ID 83704

100% SATISFACTION GUARANTEE
Comments & Questions?
800-824-1706 www.wincofoods.com

50844  REV0419A61601  WF1905

Winco 44-616

INGREDIENTS AND APPEARANCE

COLD, FLU AND SORE THROAT RELIEF  MAXIMUM STRENGTH, MULTI SYMPTOM
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-293
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, UNSPECIFIED (UNII: 2S7830E561)
FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;616
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-293-30	3 in 1 PACKAGE	04/07/2013
1		10 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	04/07/2013

Labeler - WinCo Foods, LLC (056098817)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(67091-293)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(67091-293)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(67091-293)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(67091-293)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(67091-293)