Drug Facts
Drug Labeling and Warnings
Drug Details [pdf]
NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
National Distribution Network (Smart Choice)
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.
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Drug Facts
Active ingredients (in each 30 mL, 2 tablespoons)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Uses
temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- fever
- runny nose and sneezing
- itchy nose or throat
- coughs
- cough due to minor throat and bronchial irritation
Warnings
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
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- 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
Ask a doctor before use if you have
- liver disease
- glaucoma
- 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)
Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When using this product
- 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
Stop use and ask a doctor if
- 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.
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
- take only as recommended (see overdose warning)
- do not exceed 4 doses per 24 hours
- use dosing cup provided
- tbsp=tablespoon, mL= milliliter
| age | dose |
| adults & children 12 years and over | 2 tablespoons (30 mL) every 6 hours |
| children 4 to 11 years | do not use unless directed by a doctor |
| children under 4 years | do not use |
- When using other Day Time or Night Time products, carefully read each label to insure correct dosing
Other information
- each 30 mL contains; potassium 10 mg, sodium 38 mg
- store at 20º-25ºC (68º-77ºF). Do not refrigerate.
Inactive ingredients
acesulfame potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, high fructose corn syrup, natural & artificial flavor, polyethylene glycol 300, propylene glycol, purified water, saccharin sodium, sodium citrate
Principal Display Panel
Compare to the active ingredients in Vicks® NyQuil®*
Night Time
Cold & Flu
Acetaminophen-Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Doxylamine succinate -Antihistamine
- Aches, fever, cough, runny nose and sneezing
- for ages 12 and over
- alcohol 10%
FL OZ (mL)
Cherry Flavor
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.
DISTRIBUTED BY
NATIONAL DISTRIBUTION NETWORK
P.O. BOX 875
MELVILLE, NY 11747-0875
| NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid |
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| Labeler - National Distribution Network (Smart Choice) (045099210) |
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