FDA Label for Complete Cold Relief

Active Ingredients (In Each 20 Ml)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  
  • minor aches and pains
    
  • sinus congestion and pressure
    
  • cough due to minor throat and bronchial irritation
  • headache
    
  • nasal congestion
  • sore throat
    
  • temporarily promotes nasal and/or sinus drainage
  • temporarily reduces fever
    
  • 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 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.


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

• cough that occurs with too much phlegm (mucus)
• liver disease
• thyroid disease
• heart disease
  
• difficulty in urination due to enlargement of the prostate gland
  
• high blood pressure
• diabetes
  
• 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 recommended dosage.

Stop Use And Ask A Doctor If

• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• new symptoms occur
  
• nervousness, dizziness, or sleeplessness 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 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 6 doses in any 24-hour period
  
• mL = milliliter; FL OZ = fluid ounce
  
• only use the dose cup provided
  
• adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  
• children under 12 years: do not use
  

Other Information

• each 20 mL contains: sodium 10 mg
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• use by expiration date on package
  

Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

Questions Or Comments?

1-888-779-2877 M-F 9AM-5PM EST

Principal Display Panel

NDC 27854-299-00

MAXIMUM STRENGTH

Buckleys

COMPLETE COLD RELIEF

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

RELIEVES:
✓HEADACHE, FEVER & SORE THROAT
✓CONTROLS COUGH, THINS & LOOSENS MUCUS
✓SINUS PRESSURE AND CONGESTION

ALCOHOL FREE

AGES 12 & OVER

F-005-45 ORG

6 FL OZ (177 mL)

MIXED BERRY FLAVORED

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY:
Belmora LLC
3033 Wilson Blvd. Suite 700,
Arlington, VA 22201

50844          ORG062100545

Buckleys 44-005 - buckleys 44 005 1