Cold and Flu Nighttime Relief by Freds Inc
Dosage form: liquid
Ingredients: ACETAMINOPHEN 650mg in 30mL, DEXTROMETHORPHAN HYDROBROMIDE 30mg in 30mL, DOXYLAMINE SUCCINATE 12.5mg in 30mL
Labeler: Freds Inc
NDC Code: 55315-342
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Pain reliever/fever reducer
temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- sore throat
- runny nose and sneezing
- itchy nose or throat
- cough due to minor throat and bronchial irritation
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses ( 8 tablespoons or 120 mL) in 24 hours, which is the maximum daily amount
- 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:
- 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.
- to make a child sleepy
- 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
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- liver disease
- breathing problems
- chronic bronchitis
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus)
- sedatives or tranquilizers
- the blood thinning drug warfarin
- do not use more than directed (see overdose warning)
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives and tranquilizers may increase drowsiness
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 7 days
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
ask a health professional before use.
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.
- do not take more than 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
|adults & children 12 yrs and over||30 mL every 6 hrs|
|children 4 to 11 yrs||do not use unless directed by a doctor|
|children under 4 yrs||do not use|
- When using other Day Time or Night Time products, carefully read each label to ensure correct dosing
- each 30 mL contains: potassium 10 mg, sodium 38 mg
- store between 20-25ºC (68-77ºF). Do not refrigerate.
acesulfame potassium, alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor,high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Compare to the active ingredients in Vicks® NyQuil®*
Cold & Flu
Each dose (per 30 mL) of oral solution contains:
650 mg-Acetaminophen (Pain Reliever/Fever Reducer)
30 mg- Dextromethorphan HBr (Cough Suppressant)
12.5 mg- Doxylamine succinate (Antihistamine)
- Aches, fever, cough, runny nose and sneezing
- for ages 12 and over
- alcohol 10%
FL OZ (mL)
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil®.
Failure to follow these warnings could result in serius consequences.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
|COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
|Labeler - Freds Inc (005866116)|