Best Choice 44-527C

Best Choice 44-527C

Drug Labeling and Warnings

Drug Details

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SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME- acetaminophen, guaifenesin and phenylephrine hcl tablet, film coated 
Valu Merchandisers Company

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.

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Best Choice 44-527C

Active ingredients (in each caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Expectorant
Nasal decongestant

Uses

  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • minor aches and pains
    • nasal congestion
    • sinus congestion and pressure
    • headache
  • 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 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. 

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

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
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

Best Choice®

COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL® SINUS SEVERE*

Non-Drowsy
Severe Daytime
SINUS
Congestion & Pain

ACETAMINOPHEN - Pain Reliever / Fever Reducer
Guaifenesin - Expectorant
Phenylephrine HCI - Nasal Decongestant

Relieves Headache, Fever,
Chest Congestion, Sinus
Pressure, Nasal Congestion

Pseudoephedrine Free

Actual Size

24 Cool Caplets
with Cool Blast Flavor

*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Tylenol® SINUS SEVERE.   

50844           REV0917G52708

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

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

Best Choice®
100% Guaranteed

www.bestchoicebrand.com

Best Choice 44-527C

Best Choice 44-527C

SEVERE SINUS CONGESTION AND PAIN  NON-DROWSY, DAYTIME
acetaminophen, guaifenesin and phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63941-527
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
CROSPOVIDONE (UNII: 2S7830E561)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize19mm
FlavorMINTImprint Code 44;527
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63941-527-082 in 1 CARTON08/06/2005
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/06/2005
Labeler - Valu Merchandisers Company (868703513)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(63941-527)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(63941-527)

Revised: 11/2018
 
Valu Merchandisers Company


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