SEVERE CONGESTION AND COLD RELIEF MAXIMUM STRENGTH, MULTI SYMPTOM- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated

Severe Congestion and Cold Relief by

Drug Labeling and Warnings

Severe Congestion and Cold 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
  • cough
  • headache
  • minor aches and pains
  • sinus congestion and pressure
• temporarily reduces fever
• temporarily promotes nasal and/or sinus drainage
• 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 in 24 hours, which is the maximum daily amount
  
• 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:

• blisters
• rash
• skin reddening

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

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
• cough that occurs with too much phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland
  
• heart disease
• high blood pressure
• 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 the 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
• redness or swelling is present
• fever gets worse or lasts more than 3 days
• cough comes back or occurs with rash or headache. 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 red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions?

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

Principal display panel

WinCo®
FOODS

MAXIMUM STRENGTH

Severe Congestion
& Cold Relief

Multi-Symptom

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

30
Caplets

Relieves Headache, Fever, Nasal
& Chest Congestion. Controls
Cough, Thins & Loosens Mucus

*Compare to the active ingredients in MUCINEX®

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

*This product is not manufactured or distributed
by RECKITT BENCKISER LLC, distributor of
MUCINEX®

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

50844      REV0317A61701

Winco 44-617

INGREDIENTS AND APPEARANCE

SEVERE CONGESTION AND COLD 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: 67091-294
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 RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
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)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;617
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-294-30	3 in 1 CARTON	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(67091-294)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(67091-294)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(67091-294)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(67091-294)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(67091-294)