Complete Cold Relief ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL BELMORA LLC FDA Approved Uses temporarily relieves these common cold and flu symptoms: minor aches and pains sinus congestion and pressure stuffy nose nasal congestion sore throat cough headache 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
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Substance Acetaminophen
Route
ORAL
Applications
M012
Product NDC
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg
Inactive Ingredients
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
Strengths
20 ml 650 mg 20 mg 400 mg 10 mg
Quantities
177 ml
Treats Conditions
Uses Temporarily Relieves These Common Cold And Flu Symptoms Minor Aches And Pains Sinus Congestion And Pressure Stuffy Nose Nasal Congestion Sore Throat Cough Headache 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
Pill Appearance
Color: blue

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0853030002762
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
Packaging

Principal display panel Belmora LLC 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 ✓SINUS PRESSURE AND CONGESTION ✓CONTROLS COUGH, THINS & LOOSENS MUCUS AGES 12 & OVER F-005-45 REV A 6 FL OZ (177 mL) MIXED BERRY FLAVORED TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Distributed by: Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201 50844 REV0523A00545 Buckleys 44-005 Buckleys 44-005

Package Descriptions
  • Principal display panel Belmora LLC 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 ✓SINUS PRESSURE AND CONGESTION ✓CONTROLS COUGH, THINS & LOOSENS MUCUS AGES 12 & OVER F-005-45 REV A 6 FL OZ (177 mL) MIXED BERRY FLAVORED TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Distributed by: Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201 50844 REV0523A00545 Buckleys 44-005 Buckleys 44-005

Overview

Uses temporarily relieves these common cold and flu symptoms: minor aches and pains sinus congestion and pressure stuffy nose nasal congestion sore throat cough headache 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

Indications & Usage

Uses temporarily relieves these common cold and flu symptoms: minor aches and pains sinus congestion and pressure stuffy nose nasal congestion sore throat cough headache 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

Dosage & Administration

Directions do not take more than directed do not take more than 6 doses in any 24-hour period mL = milliliter only use the dose cup provided dose as follows or as directed by a doctor adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: do not use

Warnings & Precautions
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 cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. redness or swelling is present If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of 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.
Purpose

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Do Not Use

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

When Using

When using this product do not exceed recommended dosage.

Stop Use & Ask a Doctor

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 cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. redness or swelling is present

Keep Out of Reach of Children

Keep out of reach of children. In case of 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.

Storage & Handling

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

Questions

Questions or comments? 1-888-779-2877 M-F 9AM-5PM EST


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