Theraflu Severe Cold Relief Daytime Berry Burst

ACETAMINOPHEN, DEXTROMETHORPHAN HBr · Powder, For Solution · Oral

Over the counter Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist alpha-1 Adrenergic Agonist

Active ingredient

Active ingredients (in each packet) Acetaminophen 650 mg Dextromethorphan HBr 20 mg

Purpose

Purposes Pain reliever/Fever reducer Cough suppressant

Uses

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

Warnings

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 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. 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 Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin 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 or cough 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. 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.

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.

Ask a doctor before use

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

Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor

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 or cough 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.

Pregnancy 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.

Directions

Directions do not use more than directed take 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.

Other information

Other information each packet contains: potassium 5 mg, sodium 20 mg phenylketonurics: contains phenylalanine 14 mg per packet store at controlled room temperature 20 o -25 o C (68 o - 77 o F). Protect product from heat and moisture.

Inactive ingredients

Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, 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?

Questions or comments? 1-855-328-5259

Label text from the FDA structured product label by Haleon US Holdings LLC (revised Mar 8, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Acetaminophen in 2 products
Dextromethorphan Hydrobromide in 2 products
Phenylephrine Hydrochloride in 1 product

Theraflu Severe Cold Relief Daytime Berry Burst NDC products (2)

NDC	Strength & form	Labeler	Type
0067-0106	Acetaminophen 650 mg/1; Dextromethorphan Hydrobromide 20 mg/1 Powder, For Solution	Haleon US Holdings LLC	OTC MONOGRAPH DRUG
0067-6800	Acetaminophen 650 mg/1; Dextromethorphan Hydrobromide 20 mg/1; Phenylephrine Hydrochloride 10 mg/1 Powder	Haleon US Holdings LLC	OTC MONOGRAPH DRUG

Frequently asked questions

What is Theraflu Severe Cold Relief Daytime Berry Burst used for?

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

Who makes Theraflu Severe Cold Relief Daytime Berry Burst?

Theraflu Severe Cold Relief Daytime Berry Burst is listed by 1 labeler in the FDA NDC directory, including Haleon US Holdings LLC.