Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
Capsule, Liquid Filled · Oral
Active ingredient
Active ingredient (in each Softgel) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Phenylephrine HCl USP 5 mg
Purpose
Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant
Uses
Uses Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product 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
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.
Ask a doctor before use
Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough 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.
When using this product
When using this product, do not use more than directed.
Stop use and ask a doctor
Stop use and ask a doctor if you get nervous, dizzy or sleepless 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Directions take only as directed do not exceed 8 Softgels per 24 hrs adults & children 12 years & over 2 Softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use
Inactive ingredients
Inactive ingredients D&C yellow no. 10, gelatin, glycerin, polyethylene glycol 400, povidone k 30, propylene glycol, purified water, sorbitol sorbitan solution
Label text from the FDA structured product label by Prodose, Inc. (revised Jul 24, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Phenylephrine Hydrochloride in 4 products
- Acetaminophen in 4 products
- Dextromethorphan Hydrobromide in 4 products
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 14803-909 | Phenylephrine Hydrochloride 5 mg/1; Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1 Capsule, Liquid Filled | Elysium Pharmaceuticals Ltd | DRUG FOR FURTHER PROCESSING |
| 68210-5053 | Phenylephrine Hydrochloride 5 mg/1; Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1 Capsule, Liquid Filled | Prodose, Inc. | OTC MONOGRAPH DRUG |
| 35916-0155 | Phenylephrine Hydrochloride 5 mg/1; Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1 Capsule, Liquid Filled | SOFTGEL HEALTHCARE PRIVATE LIMITED | OTC MONOGRAPH DRUG |
| 35916-0917 | Phenylephrine Hydrochloride 5 mg/1; Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1 Capsule, Liquid Filled | SOFTGEL HEALTHCARE PRIVATE LIMITED | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride used for?
Uses Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever
Who makes Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride?
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride is listed by 3 labelers in the FDA NDC directory, including Elysium Pharmaceuticals Ltd, Prodose, Inc., SOFTGEL HEALTHCARE PRIVATE LIMITED.