THERAFLU NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine, phenylephrine powder, for solution
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
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 ingredient
Acetaminophen, 650 mg
Diphenhydramine hydrochloride, 25 mg
Phenylephrine hydrochloride, 10 mg
Uses
- •
- temporarily relieves these symptoms due to a cold:
• minor aches and pains • minor sore throat pain
• headache • nasal and sinus congestion
• runny nose • sneezing
• itchy nose or throat • itchy, watery eyes due to hay fever
• cough due to minor throat and bronchial irritation
- •
- temporarily reduces fever
Warnings
Liver warning: 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 Doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- glaucoma
- •
- 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.
Directions
- •
- 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
|
Age |
Dose |
|
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 with 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.
Other information
- •
- each packet contains: potassium 10 mg, sodium 23 mg
- •
- phenylketonurics: contains phenylalanine 13 mg per packet
- •
- store at controlled room temperature 20-25°C (68-77°F). Protect from excessive heat and moisture.
Inactive ingredients
acesulfame K, aspartame, citric acid, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate
Additional Information Listed On Other Panels
Theraflu®
Nighttime
Severe Cold & Cough
ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
- •
- Nasal Congestion
- •
- Cough
- •
- Runny Nose
- •
- Sneezing
- •
- Body Ache
- •
- Sore Throat Pain
- •
- Headache
- •
- Fever
| THERAFLU
NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine, phenylephrine powder, for solution |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |