Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride
Capsule, Liquid Filled · Oral
Active ingredient
Active ingredients (in each Capsule) Acetaminophen USP 325 mg Dextromethorphan Hydrobromide USP 10 mg Doxylamine Succinate USP 6.25 mg Phenylephrine Hydrochloride USP 5 mg
Purpose
Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Uses
Uses temporarily relieves these symptoms due to cold/flu: minor aches and pains headache nasal and sinus congestion cough sore throat runny nose sneezing 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 hives facial swelling asthma(wheezing) shock If a skin or general allergic 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 to sedate children.
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 in children under 12 years of age
Ask a doctor before use
Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlaragement of the prostate gland 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 taking sedatives or tranquilizers
When using this product
When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, 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 occurs
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 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 the recommended dose adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 4 capsules in 12 hours or as directed by a doctor. children under 12 years: do not use
Inactive ingredients
Inactive ingredients candurin silver sheen, candurin silver sparkle, D&C yellow no.10, FD&C blue no.1, gelatin, glycerin, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution
Label text from the FDA structured product label by Softgel Healthcare Pvt Ltd (revised Apr 27, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Phenylephrine Hydrochloride in 3 products
- Acetaminophen in 3 products
- Dextromethorphan Hydrobromide in 3 products
- Doxylamine Succinate in 3 products
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 14803-907 | Phenylephrine Hydrochloride 5 mg/1; Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Doxylamine Succinate… Capsule, Liquid Filled | Elysium Pharmaceuticals Ltd | DRUG FOR FURTHER PROCESSING |
| 35916-0167 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1; Doxylamine Succinate… Capsule, Liquid Filled | SOFTGEL HEALTHCARE PRIVATE LIMITED | OTC MONOGRAPH DRUG |
| 35916-0186 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1; Doxylamine Succinate… Capsule, Liquid Filled | Softgel Healthcare Pvt Ltd | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride used for?
Uses temporarily relieves these symptoms due to cold/flu: minor aches and pains headache nasal and sinus congestion cough sore throat runny nose sneezing temporarily reduces fever
Who makes Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride?
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride is listed by 3 labelers in the FDA NDC directory, including Elysium Pharmaceuticals Ltd, SOFTGEL HEALTHCARE PRIVATE LIMITED, Softgel Healthcare Pvt Ltd.