Cold Flu and Sore Throat
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE · Tablet, Coated · Oral
Active ingredient
Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Purpose
Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Uses
Uses temporarily relieves these common cold and flu symptoms: headache cough nasal congestion sore throat minor aches and pains temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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: blisters rash skin reddening 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 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have high blood pressure diabetes thyroid disease heart disease liver disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, 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.
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 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. if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use
Ask a doctor before use if you have high blood pressure diabetes thyroid disease heart disease liver disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product
When using this product do not exceed recommended dosage.
Stop use and ask a doctor
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, 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.
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 take more than directed do not take more than 12 caplets in any 24-hour period adults and children 12 years and over: take 2 caplets every 4 hours children under 12 years: do not use
Other information
Other information each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Inactive ingredients
Inactive ingredients corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions?
Questions or comments? 1-800-426-9391
Label text from the FDA structured product label by Meijer Distribution, Inc. (revised Aug 24, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 7 products
- Dextromethorphan Hydrobromide in 7 products
- Guaifenesin in 7 products
- Phenylephrine Hydrochloride in 7 products
Cold Flu and Sore Throat NDC products (7)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 53942-516 | Acetaminophen 650 mg/20mL; Dextromethorphan Hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL; Phenylephrine… Liquid | DeMoulas Market Basket | OTC MONOGRAPH DRUG |
| 55319-705 | Acetaminophen 650 mg/20mL; Dextromethorphan Hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL; Phenylephrine… Solution | Family Dollar Services Inc | OTC MONOGRAPH DRUG |
| 79481-6171 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Meijer Distribution, Inc. | OTC MONOGRAPH DRUG |
| 56062-197 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Coated | PUBLIX SUPER MARKETS INC | OTC MONOGRAPH DRUG |
| 72476-197 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Coated | RETAIL BUSINESS SERVICES , LLC. | OTC MONOGRAPH DRUG |
| 0363-8005 | Acetaminophen 650 mg/20mL; Dextromethorphan Hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL; Phenylephrine… Solution | Walgreen Company | OTC MONOGRAPH DRUG |
| 0363-9016 | Acetaminophen 325 mg/1; Guaifenesin 200 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule, Liquid Filled | Walgreens | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Cold Flu and Sore Throat used for?
Uses temporarily relieves these common cold and flu symptoms: headache cough nasal congestion sore throat minor aches and pains temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Who makes Cold Flu and Sore Throat?
Cold Flu and Sore Throat is listed by 7 labelers in the FDA NDC directory, including DeMoulas Market Basket, Family Dollar Services Inc, Meijer Distribution, Inc., PUBLIX SUPER MARKETS INC.