Drug Facts
Active ingredients (in each 30 mL dose cup)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Nighttime Cold And Flu (NDC 37835-525). 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 drug facts, 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.
Active ingredients (in each 30 mL dose cup)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
Pain Reliever/Fever Reducer
Cough Suppressant
Antihistamine
temporarily relieves common cold/flu symptoms:
• sore throat
• minor aches and pains
• runny nose and sneezing
• headache
• fever
• cough due to minor throat and bronchial irritation.
Liver warning:This product contains acetaminophen. Severe liver damage may occur if:
• adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product.
Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening
• blisters
• rash. If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning:If sore throat is severe, lasts for mroe than 2 days, is accompanied or followed by fever, heacache, rash, nausea, or vomiting, consult 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.
• if you have ever had an allergic reaction to this product or anay of its ingredients
• liver disease
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occur with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to an enlarged prostate gland.
• do not use more than directed (see overdose warning)
• avoid alcoholic drinks
• excitability may occur, especially in children
• marked drowsiness may occur
• 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.
Keep out of the reach of children.
Taking mroe than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately.Quick 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)
• measure only with dosing cup provided and keep dosage cup with product
• mL=mililiter
• do not exceed 4 doses per 24 hours
| Age | Dose |
| adults and children 12 years and over | 30 mL every 6 hours |
| children under 12 years | do not use |
• Each 30 mL dose cup contains:sodium 10 mg
• store at room temperature 15-30°C (59-86°F) and do not refrigerate
citric acid, D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
1-844-912-4012
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