Active Ingredients (In Each 20 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by Belmora Llc for the product Complete Cold Relief (NDC 27854-299). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 20 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
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.
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
ask a health professional before use.
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.
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
1-888-779-2877 M-F 9AM-5PM EST
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
PARENTS: |
DISTRIBUTED BY:
Belmora LLC
3033 Wilson Blvd. Suite 700,
Arlington, VA 22201
50844 ORG062100545
* Please review the disclaimer below.