Active Ingredients (In Each 15 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Cold And Flu Solution
FDA Label NDC 37835-526
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Cold And Flu (NDC 37835-526). 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 15 ml), purpose, uses, warnings, do not use, ask a doctor before use if the user has, ask a doctor or pharmacist before use if the user is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- nasal congestion
- fever
- headache
- minor aches and pains
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
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 The User Has
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- liver disease
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- heart disease
- diabetes
- thyroid disease
- high blood pressure
Ask A Doctor Or Pharmacist Before Use If The User Is
taking the blood thinning drug warfarin.
When Using This Product
do not exceed recommended dosage.
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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 or symptoms.
Directions
- do not take more than directed
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- do not take more than 5 doses per 24 hours
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children under 6 years | do not use |
Other Information
- each 15 mL contains: sodium 13 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 yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose
Questions Or Comments?
1-800-935-6737
Principal Display Panel
BI-MART
Compare to the active ingredients
in Vicks® DayQuil® Cold & Flu
Multi-Symptom Relief*
Non-drowsy
DAYTIME
COLD & FLU
Acetaminophen (Pain reliever/fever reducer)
Dextromethorphan HBr (Cough suppressant)
Phenylephrine HCl (Nasal decongestant)
Multi-Symptom Relief
• Aches, Fever & Sore Throat
• Cough
• Nasal Congestion
Alcohol Free/ Antihistamine Free
12 FL OZ (354 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
BI-MART UNCONDITIONAL MONEY BACK GUARANTEE
If you are not completely satisfied with your BI-MART
QUALITY PRODUCT, regardless of the reason, return the
unused portion and your entire purchase price will be
cheerfully refunded.
*This product is not manufactured or
distributed by Procter & Gamble
distributor of Vicks® DayQuil®
Cold & Flu Multi-Symptom Relief.
50844 ORG031801202
Distributed by:
BI-MART
Eugene, OR 97402
Bi-mart 44-012 (Bi Mart 44 012 1)
* Please review the disclaimer below.
