Theraflu
8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each tablet) Purpose Acetaminophen 500 mg Pain reliever/Fever reducer Dextromethorphan HBr 20 mg Cough Suppressant
Medication Information
Description
Active ingredients (in each tablet) Purpose Acetaminophen 500 mg Pain reliever/Fever reducer Dextromethorphan HBr 20 mg Cough Suppressant
Uses
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Section 50565-1
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.
Section 53414-9
If pregnant or breast-feeding,ask a health professional before use.
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 directed
- take every 4 hours, while symptoms persist. Do not take more than 6 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 a 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.
Other Information
- each packet contains:potassium 10 mg, sodium 20 mg
- phenylketonurics:contains phenylalanine 20 mg per packet
- store at controlled room temperature 20 o-25 oC (68 o- 77 oF). Protect product from heat and moisture.
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no.10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate
Questions Or Comments?
1-855-328-5259
Principal Display Panel
THERAFLU SEVERE COLD RELIEF - Acetaminophen, Dextromethorphan HBr - NDC 70264-047-01 - 25s Packets Caton Label
Stop Use and Ask A Doctor If
- 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.
Ask Doctor Before Use If You Have
- liver disease
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Active Ingredients (in Each Packet)
| Active ingredients (in each tablet) | Purpose |
|---|---|
| Acetaminophen 500 mg | Pain reliever/Fever reducer |
| Dextromethorphan HBr 20 mg | Cough Suppressant |
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
Structured Label Content
Uses
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Section 50565-1 (50565-1)
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.
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a health professional before use.
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 directed
- take every 4 hours, while symptoms persist. Do not take more than 6 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 a 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.
Other Information (Other information)
- each packet contains:potassium 10 mg, sodium 20 mg
- phenylketonurics:contains phenylalanine 20 mg per packet
- store at controlled room temperature 20 o-25 oC (68 o- 77 oF). Protect product from heat and moisture.
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, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate
Questions Or Comments? (Questions or comments?)
1-855-328-5259
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
THERAFLU SEVERE COLD RELIEF - Acetaminophen, Dextromethorphan HBr - NDC 70264-047-01 - 25s Packets Caton Label
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
- 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.
Ask Doctor Before Use If You Have (Ask doctor before use if you have)
- liver disease
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Active Ingredients (in Each Packet) (Active ingredients (in each packet))
| Active ingredients (in each tablet) | Purpose |
|---|---|
| Acetaminophen 500 mg | Pain reliever/Fever reducer |
| Dextromethorphan HBr 20 mg | Cough Suppressant |
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
- taking the blood thinning drug warfarin
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:14.543105 · Updated: 2026-03-14T23:10:29.645873