THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT- acetaminophen, diphenhydramine hcl, phenylephrine hcl syrup
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.
----------
Drug Facts
Active ingredients (in each 30 mL)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 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 4,000 mg of acetaminophen in 24 hours
- •
- with other drugs containing acetaminophen
- •
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- •
- skin reddening
- •
- blisters
- •
- rash
- If a skin reaction occurs, stop use and seek medical help right away.
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 12 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.
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- glaucoma
- •
- trouble urinating due to an enlarged prostate gland
- •
- a breathing problem such as emphysema 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
- •
- taking 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
- •
- pain, cough or nasal congestion 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.
Directions
- •
- do not use more than directed
- •
- measure the dose correctly using the enclosed dosing cup
- •
- take every 4 hours in dosing cup provided, while symptoms persist
- •
- do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor
|
|
|
|
|
|
Other information
- •
- each 30 mL contains: potassium 25 mg, sodium 16 mg
- •
- store at controlled room temperature 20-25°C (68-77°F)
Inactive ingredients
acesulfame potassium, alcohol, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate
Principal Display Panel
NDC 0067-8131-08
THERAFLU®
ExpressMax™
FLU, COUGH & SORE THROAT
BERRY FLAVOR
ACETAMINOPHEN - PAIN RELIEVER/FEVER REDUCER
DIPHENHYDRAMINE HCL – ANTIHISTAMINE/COUGH SUPPRISSANT
PHENYLEPHRINE HCL – NASAL DECONGESTANT
•NASAL CONGESTION • HEADACHE • SORE THROAT PAIN •RUNNY NOSE • BODY ACHE •COUGH • FEVER
8.3 FL OZ (245.5Ml)
Alcohol Content: 10%
*Maximum Strength per 4 hour dose.
Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622
©2015
12269
www.theraflu.com
| THERAFLU EXPRESSMAX
FLU, COUGH, AND SORE THROAT
acetaminophen, diphenhydramine hcl, phenylephrine hcl syrup |
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |