FDA Label for Theraflu Severe Cold Relief Daytime Berry Burst

Active Ingredients (In Each Packet)

Acetaminophen 650 mg

Dextromethorphan HBr 25 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Uses

• •temporarily relieves these symptoms due to a cold:
  • •minor aches and pains
  • •minor sore throat pain
  • •headache
  • •nasal and sinus congestion
  • •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 the blood thinning drug warfarin

When Using This Product

• •do not exceed recommended dosage

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 last more than 7 days
• •cough comes back or occurs with rash or headache that lasts.

  These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health 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.

Directions

• •do not use more than directed
• •take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor
AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not use
• •dissolve contents of one packet into 8 oz. hot water; sip while hot. Consumer 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.

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 product from heat and moisture.

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Questions Or Comments?

call 1-800-328-5259

Generic Section

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.com

TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN

1-855-328-5259

Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2022 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies. 62000000075406

HOT LIQUID THERAPY
that relieves:

Nasal and sinus congestion Cough

Sore throat pain Headache

Fever

CARTON
RECYCLE

Principal Display Panel

NDC 0067-6800-02

MULTI-SYMPTOM COLD RELIEF

THERAFLU

SEVERE

COLD RELIEF

NIGHTTIME

ACETAMINOPHEN
Paint Reliever/Fever Reducer

Dextromethorphan HBr
Cough Suppressant

PHENYLEPHRINE HCl
Nasal Decongestant

DAYTIME FORMULA

Hot liquid therapy
that relieves:

/ Nasal and sinus congestion
/ Cough
/ Sore throat pain
/ Headache
/ Fever

Berry Burst

6 PACKETS