Night Time Cold and Flu Original
Medically reviewed on July 20, 2017
Dosage form: liquid
Ingredients: ACETAMINOPHEN 650mg in 30mL, DEXTROMETHORPHAN HYDROBROMIDE 30mg in 30mL, DOXYLAMINE SUCCINATE 12.5mg in 30mL
Labeler: Marc Glassman, Inc.
NDC Code: 68998-531
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, USP 650 mg
Dextromethorphan HBr, USP 30 mg
Doxylamine succinate, USP 12.5 mg
Pain reliever/fever reducer
temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- minor aches and pains
- runny nose and sneezing
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
- 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.
- to make a child sleep
- liver disease
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
- a sodium-restricted diet
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
- do not use more than directed
- 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
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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 can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- take only as directed - see Overdose warning
- use dose cup or tablespoon (TBSP)
- do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours
- mL = milliliter; TBSP = tablespoon
|adults & children 12 years & over||30 mL (2 TBSP) every 4 hours
|children 4 to under 12 years||ask a doctor
|children under 4 years||do not use
- when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
- each 30 mL dose cup contains: potassium 5 mg, sodium 37 mg
- store at 20° to 25°C (68° to 77°F)
Tamper Evident: Do not use if printed shrinkband is missing or broken.
Failure to follow these warnings could result in serious consequences
acesulfame potassium, alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavors, high fructose corn syrup,polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Marc Glassman, Inc.
West 130th Street
Cleveland, OH 44130
*Compare to the active ingredients
in Vicks® NyQuil® Cold & Flu
COLD & FLU
Acetaminophen (Pain reliever/fever reducer)
Doxylamine succinate (Antihistamine)
Dextromethorphan HBr (Cough suppressant)
- Aches, Fever & Sore Throat
- Sneezing, Runny Nose
|NIGHT TIME COLD AND FLU ORIGINAL
acetaminophen, doxylamine succinate, and dextromethorphan hbr liquid
|Labeler - Marc Glassman, Inc. (094487477)|
|Registrant - Aurohealth LLC (078728447)|