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Multi-Symptom Cold Severe, Non-Drowsy, Daytime

Medically reviewed on January 22, 2018

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Valu Merchandisers Company
NDC Code: 63941-503

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Best Choice 44-503A

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:
    • sore throat
    • cough
    • nasal congestion
    • headache
    • minor aches and pains
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

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
  • 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:

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

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.

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
  • 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
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL®
COLD MULTI-SYMPTOM SEVERE*

Best
Choice®

Non-Drowsy
Severe Daytime
Multi-Symptom Cold

ACETAMINOPHEN -
Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

Actual Size

Relieves Fever/Headache,
Sore Throat, Nasal Congestion,
Cough, Chest Congestion
Pseudoephedrine Free

24 Cool Caplets
with Cool Blast Flavor

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 McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Multi-Symptom Severe.
50844          REV0316A50308

PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.
5000 KANSAS AVE
KANSAS CITY, KS 66106

Best Choice®
100% Guaranteed

www.bestchoicebrand.com

Best Choice 44-503A

MULTI-SYMPTOM COLD  SEVERE, NON-DROWSY, DAYTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-503
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
SILICON DIOXIDE 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
CROSPOVIDONE, UNSPECIFIED 
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize19mm
FlavorMINTImprint Code44;503
Contains    
Packaging
#Item CodePackage Description
1NDC:63941-503-082 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/04/2005
Labeler - Valu Merchandisers Company (868703513)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(63941-503)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(63941-503)

 
Valu Merchandisers Company

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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