Sanaflu Xtra

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride · Capsule, Gelatin Coated · Oral

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

Active ingredient

Active ingredients (in each capsule) Acetaminophen 250 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Purposes Pain reliever - fever reducer Antihistamine Cough Suppressant Nasal Decongestant

Uses

Uses Temporarily relives minor aches and pains headache runny nose sneezing nasal congestion itchy, watery eyes due to hay fever or other upper respiratory allergies itching of the nose or throat cough due to minor throat and bronchial irritation as may occur with the common cold ro inhaled irritants Temperarily 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. Do not use 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 monamine 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 a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure difficulty in urination due to enlargement of the prostate gland persistant or chrnoic cough such as occurs with smoking, asthma, or emphysema cough accompanied by excessive phlegm thyroid disease diabetes Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedativies or tranquilizers When using this product do not use more than directed may cause marked drowsiness alcohol, sedativies, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery may cause excitability, especially in children. Stop use and ask a doctor if pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occur. 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 critial even if you do not notice any signs or symptoms.

Do not use

Do not use 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 monamine 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 a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure difficulty in urination due to enlargement of the prostate gland persistant or chrnoic cough such as occurs with smoking, asthma, or emphysema cough accompanied by excessive phlegm thyroid disease diabetes

Ask a doctor or pharmacist

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

When using this product

When using this product do not use more than directed may cause marked drowsiness alcohol, sedativies, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery may cause excitability, especially in children.

Stop use and ask a doctor

Stop use and ask a doctor if pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occur.

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 critial even if you do not notice any signs or symptoms.

Directions

Directions Adults and children 12 years of age and older: Take 2 capsules every 4 hours; not more than 12 capsules in 24 hours. Children under 12 years of age: Consult a doctor.

Other information

Other information Store at room temperature in a dry place.

Inactive ingredients

Inactive ingredients D&C Red 33, FD&C Blue 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, polyvinylpyrrolidone, propylene glycol, sodium methylparaben, sodium propylparaben, water

Label text from the FDA structured product label by GRANDALL DISTRIBUTING, LLC (revised Oct 28, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Sanaflu Xtra NDC products (1)

NDCStrength & formLabelerType
48201-001Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1; Acetaminophen 250 mg/1; Chlorpheniramine…
Capsule, Gelatin Coated
GRANDALL DISTRIBUTING, LLCOTC MONOGRAPH DRUG

Frequently asked questions

What is Sanaflu Xtra used for?

Uses Temporarily relives minor aches and pains headache runny nose sneezing nasal congestion itchy, watery eyes due to hay fever or other upper respiratory allergies itching of the nose or throat cough due to minor throat and bronchial irritation as may occur with the common cold ro inhaled irritants Temperarily reduces fever

Who makes Sanaflu Xtra?

Sanaflu Xtra is listed by 1 labeler in the FDA NDC directory, including GRANDALL DISTRIBUTING, LLC.