Theraflu Severe Cold Relief Nighttime, Honey (honey Lemon Flavor)

Theraflu Severe Cold Relief Nighttime, Honey (honey Lemon Flavor)
SPL v1
SPL
SPL Set ID 6ee1cc52-2d7e-4b53-a0e6-563e623bcb51
Route
ORAL
Published
Effective Date 2024-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Aspartame D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Maltodextrin Silicon Dioxide Sodium Citrate Soybean Lecithin Sucrose Tribasic Calcium Phosphate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-01

Description

Acetaminophen 650 mg Diphenhydramine HCl 25 mg

Purpose

Pain reliever/Fever reducer Antihistamine/Cough suppressant


Medication Information

Purpose

Pain reliever/Fever reducer Antihistamine/Cough suppressant

Description

Acetaminophen 650 mg Diphenhydramine HCl 25 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

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

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.

Directions

do not use more than directedtake every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.

 Age  Dose
 adults and children 12 years of age and over  one packet
 children under 12 years of age  do not use

• 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.

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.

Drug Facts

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.

Package Labeling:

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, f lavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate 

Questions Or Comments?

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

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

Stop Use and Ask A Doctor If

• 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 • pain, cough or nasal congestion gets worse or lasts more than 7 days These could be signs of a serious condition.

Ask A Doctor Or pharmacist 

before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin

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.

Active Ingredients (in Each Packet)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg


Structured Label Content

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

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

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.

Directions

do not use more than directedtake every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.

 Age  Dose
 adults and children 12 years of age and over  one packet
 children under 12 years of age  do not use

• 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.

Do Not Use (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.

Drug Facts

Other Information (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.

Package Labeling:

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, f lavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate 

Questions Or Comments? (Questions or comments?)

1-855-328-5259

When Using This Product (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

Ask A doctor Before Use If (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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• 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 • pain, cough or nasal congestion gets worse or lasts more than 7 days These could be signs of a serious condition.

Ask A Doctor Or pharmacist  (Ask a doctor or pharmacist )

before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Active Ingredients (in Each Packet) (Active ingredients (in each packet))

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)