Nighttime Flu and Severe
Dosage form: powder, for solution
Ingredients: Acetaminophen 650mg, Diphenhydramine Hydrochloride 25mg, Phenylephrine Hydrochloride 10mg
Labeler: Taro Pharmaceuticals U.S.A. Inc.
NDC Code: 51672-2113
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.
Flu and Severe
|Active ingredients (in each packet)||Purposes|
|Acetaminophen 650 mg||Pain reliever/fever reducer|
|Diphenhydramine hydrochloride 25 mg||Antihistamine/cough suppressant|
|Phenylephrine hydrochloride 10 mg||Nasal decongestant|
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- nasal and sinus congestion
- runny nose
- itchy nose or throat
- itchy, watery eyes due to hay fever
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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
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.
- in a child under 4 years of age
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on the skin
- 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.
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema, asthma or chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
- do not exceed recommended dosage
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- symptoms do not get better or worsen
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a heath care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not use more than directed
- take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor
|children under 4 years of age||do not use|
|children 4 to under 12 years of age||do not use unless directed by a doctor|
|adults and children 12 years of age and over||one packet|
- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
- each packet contains: potassium 4 mg, sodium 27 mg
- phenylketonurics: contains phenylalanine 34 mg per packet
- store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.
acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Compare to the active
ingredients in Theraflu®
Nighttime Severe Cold & Cough*
See New Warnings
Information & Directions
Flu & Severe
Cold & Cough
Acetaminophen - Pain reliever/fever reducer
Diphenhydramine HCl - Antihistamine/cough suppressant
Phenylephrine HCl - Nasal decongestant
- Nasal Congestion
- Sore Throat Pain
- Body Ache
- Runny Nose
Chamomile & White Tea Flavors
FLU AND SEVERE
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution
|Labeler - Taro Pharmaceuticals U.S.A. Inc. (145186370)|
|Taro Pharmaceutical Industries Ltd.||600072078||MANUFACTURE(51672-2113)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.