COMPLETE COLD RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution 
Belmora LLC

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Buckleys 44-005

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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.

Directions

Other information

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

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

COMPLETE COLD RELIEF 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-299
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27854-299-00177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/23/2022
Labeler - Belmora LLC (112753244)

Revised: 12/2023
Document Id: 76fd7f91-dc2c-49ac-9516-b696023d2bca
Set id: a81fc021-9a9f-4cec-a1a6-73e3f983b78d
Version: 3
Effective Time: 20231214
 
Belmora LLC