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Cold Multi-Symptom Severe by L&R Distributors, Inc.

Medically reviewed on April 6, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: L&R Distributors, Inc.
NDC Code: 15127-962

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.

Select Brand 44-503A-CMS

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
    • headache
    • cough
    • nasal congestion
    • 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. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen 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
  • liver disease
  • diabetes
  • heart disease
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • thyroid disease
  • 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
  • persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent 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
  • 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, 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

select brand®
the lower price name brand

NDC 15127-962-24

Cold
Multi-Symptom
SEVERE

Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Guaifenesin
Expectorant
Phenylephrine HCl
Nasal Decongestant
Fever, Headache, Sore Throat,
Nasal Congestion, Coughing, Chest Congestion

*Compare to the Active Ingredients of Tylenol® Cold Multi-Symptom Severe

24 COOL CAPLETS with Cool Blast Flavor

Daytime
Non-Drowsy

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

Distributed by:
SELECT BRAND® DISTRIBUTORS

Pine Bluff, AR 71603 USA
AC (870) 535-3635

Select Brand 44-503A

COLD MULTI-SYMPTOM  SEVERE
acetaminophen, dextromethorphan hbr, phenylephrine hcl and guaifenesin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-962
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
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
SUCRALOSE 
TITANIUM DIOXIDE 
TALC 
STARCH, CORN 
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize19mm
FlavorMINTImprint Code44;503
Contains    
Packaging
#Item CodePackage Description
1NDC:15127-962-241 BLISTER PACK in 1 CARTON
124 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 - L&R Distributors, Inc. (012578514)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(15127-962)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(15127-962)

 
L&R Distributors, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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