- Clinical Pharmacology
- Indications & Usage
- Side Effects
- Dosage & Administration
- How Supplied
- Patient Counseling Information
- Supplemental Patient Material
- Boxed Warning
- Patient Package Insert
FULL PRESCRIBING INFORMATION: CONTENTS*
- Other information
- Inactive ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 6 Packet Carton
FULL PRESCRIBING INFORMATION
|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:
- 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
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 packets 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 followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.
Do not use
- 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, as a doctor or a 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.
Ask a doctor before use if you have
- 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
When using this product
- 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
Stop use and ask a doctor if
- 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 6 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 from excessive 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.
Questions or Comments?
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
PRINCIPAL DISPLAY PANEL - 6 Packet Carton
Compare to the active
ingredient in Theraflu ®
Nighttime Severe Cold & Cough*
See New Warnings
Flu & Severe
Cold & Cough
Acetaminophen - Pain reliever/fever reducer
Diphenhydramine HCl - Antihistamine/cough suppressant
Phenylephrine HCl - Nasal decongestant
- Nasal Congestion
- Runny Nose
- Body Ache
- Sore Throat Pain
Chamomile & White Tea Flavors
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride POWDER, FOR SOLUTION