Active Ingredients (In Each 15 Ml)
Acetaminophen 325 mg
Dextromethoprhan HBr 10 mg
Phenlyephrine HCl 5 mg
Cold And Flu Relief Liquid
FDA Label NDC 55910-366
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Inc. (dollar General & Rexall) for the product Cold And Flu Relief (NDC 55910-366). 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), purposes, 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
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- fever
- nasal congestion
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- adult take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount
- child take more than 4 doses (15 mL each) in 24 hours
- take with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks everyday while using this product
- skin reddening
- blisters
- rash
Allery 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
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If The User Has
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a sodium-restricted diet
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough accompanied by excessive phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
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
- redness or swelling is present
- new symptoms occur
- nervousness, dizziness or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- 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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 (see overdose warning)
- do not exceed 4 doses in any 24 hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL=milliliter
- When using Day Time and Night Time products, carefully read each label to ensure correct dosing
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children 4 to under 6 years | ask a doctor |
| children under 4 years | do not use |
Other Information
- each 15 mL contains: sodium 12 mg
- store between 20-25°C (68-77°F)
- do not refrigerate
Inactive Ingredients
citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
Call 1-888-309-9030
Principal Display Panel
Compare to the active ingredients in VICKS® DAYQUIL® Cold & Flu*
Daytime
Cold & Flu Relief
Acetaminophen 325 mg
Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg
Cough Suppressant
Phenylephrine HCl 5 mg
Nasal Decongestant
- Aches, fever & sore throat
- Cough
- Nasal congestion
- Alcohol free
- Antihistamine free
- Non-drowsy
- Multi-symptom
For ages 6 years and over
Original Flavor
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by The Procter & Gamble Company.Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.
DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
Package Label
DOLLAR GENERAL HEALTH Day Time Cold & Flu Relief
* Please review the disclaimer below.
