Nitetime Oral Liquid
Generic Name: acetaminophen, dextromethorphan hydrobromide and doxylamine succinate
Dosage Form: oral liquid
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.
Publix Super Markets, Inc. NiteTime Cold/Flu Relief Liquid Drug Facts
Active ingredient (in each 15 mL tablespoon)
Acetaminophen 500 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses 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
Sore throat warning: If sore throat is severe, persists for more than two 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.
- to make a child sleepy
Ask a doctor before use if you have
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough as occurs with smoking, asthma or emphysema
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- 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
Directions
- take only as recommended – see Liver warning
- use dose cup
- do not exceed 4 doses per 24 hours
| adults and children 12 years and over | 30 mL (2 TBSP) every 6 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 insure correct dosing
Inactive ingredients
alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Principal Display Panel
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Original Flavor
NiteTime
Acetaminophen – Aches, Fever
Dextromethorphan HBr – Cough
Doxylamine Succinate – Sneezing, Runny Nose
Antihistamine, Cough Suppressant, Fever Reducer, Pain Reliever
Multi-Symptom
Cold/Flu Relief
Alcohol 10%
Compare to Active Ingredients in NyQuil®
Nite Time Cold/Flu Relief Liquid Label
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| Labeler - Publix Super Markets Inc (006922009) |
