FDA Label for Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack

View Indications, Usage & Precautions

ACTIVE INGREDIENTS (IN EACH CAPLET)
PURPOSES
USES
WARNINGS
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
WHEN USING THIS PRODUCT
OTHER SAFETY INFORMATION
PRINCIPAL DISPLAY PANEL

Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Caplet)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Acetaminophen 500 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 15 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Pain Reliever/Fever reducer

Antihistamine

Cough suppressant

Uses

•temporarily relieves these symptoms due to a common cold:
- •headache
- •minor aches and pains
- •cough due to minor throat and bronchial irritation
- •minor sore throat pain
- •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.

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.
•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.

•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.
•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 a MAO, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

•liver disease
•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

•liver disease
•a breathing problem such as emphysema or chronic bronchitis
•glaucoma
•trouble urinating due to an enlarged prostate gland
•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

•taking the blood thinning drug warfarin
•taking sedatives or tranquilizers

Stop Use And Ask A Doctor If

•Pain or cough gets worse or lasts more than 7 days
•fever gets worse or lasts more than 3 days
•redness or swelling is present
•new symptoms occur
•cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.

•pain or cough gets worse or lasts more than 7 days
•fever gets worse or lasts more than 3 days
•redness or swelling is present
•new symptoms occur
•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
•Adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
•do not take more than 6 caplets in 24 hours unless directed by a doctor
•children under 12 years of age: do not use

•do not use more than directed
•Adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
•do not take more than 6 caplets in 24 hours unless directed by a doctor
•children under 12 years of age: do not use

Other Information

•store at controlled room temperature 20-25°C (68-77°F)

•store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients

crospovidone, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl

alcohol, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

crospovidone, FD&C blue no. 2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, sodium starch

glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?

call 1-855-328-5259

1-855-328-5259

When Using This Product

•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

Other Safety Information

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS: Learn about teen medicine abuse

www.StopMedicineAbuse.org

*Maximum Strength per 6 hour dose.

TAMPER-EVIDENT FEATURE: THERAFLU FLU RELIEF MAX STRENGTH CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.

READ ALLWARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 6 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

B-0630-770771-10 REV A

Principal Display Panel

NDC 0067-8161-01

THERAFLU

FLU RELIEF

MAX STRENGTH*

MULTI-SYMPTOM FLU RELIEF

Powerful fever fighting formula that relieves:

/ Body ache / Headache

/ Sore throat pain / cough

/ Runny nose (Nighttime only)

DAYTIME

Acetaminophen

Pain Reliever / Fever Reducer

Dextromethorphan HBr

Cough Suppressant

NIGHTTIME