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Sinus Severe Cold Multi-Symptom

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-870

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.

LNK 44-526

Active ingredients (in each caplet)

Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant

Uses
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • headache
    • minor aches and pains
    • nasal congestion
    • cough
    • sore throat
  • temporarily reduces fever
  • temporarily relieves sinus congestion and pressure 

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:

  • 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 a 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
  • with any other product containing diphenhydramine, even one used on skin
  • 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
  • heart disease
  • diabetes
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • high blood pressure
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product
  • do not exceed recommended dose
  • excitability may occur, especially in children
  • avoid alcoholic beverages
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery 

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 of symptoms.

Directions
  • do not use more than directed
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: do not use

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, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

 1-800-426-9391

Principal Display Panel - Walgreens 

Walgreens 44-526


Principal Display Panel - Rite Aid

Rite Aid 44-526


SINUS SEVERE COLD  MULTI-SYMPTOM
acetaminophen, diphenhydramine hcl and phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-870
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
STARCH, CORN 
CROSPOVIDONE 
MICROCRYSTALLINE CELLULOSE 
POLYVINYL ALCOHOL, UNSPECIFIED 
SILICON DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint Code44;526
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-870-082 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:50844-870-073 BLISTER PACK in 1 CARTON
212 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/21/2005
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(50844-870)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(50844-870)

 
L.N.K. International, Inc.

Medically reviewed on Jan 18, 2018

Further information

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

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