Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
Capsule, Liquid Filled · Oral
Active ingredient
Active ingredients(in each Softgel) Acetaminophen USP 325 mg Dextromethorphan HBr USP 15 mg Doxylamine succinate USP 6.25 mg
Purpose
Purpose Pain reliever/Fever reducer Cough suppressant Antihistamine
Uses
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing
Warnings
Warnings Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take more than 8 softgels in 24 hours, 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 glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin
When using this product
When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, & tranquilizers may increase drowsiness
Stop use and ask a doctor
Stop use and ask a doctor if pain 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 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Inactive ingredients
Inactive ingredients D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, sorbitol sorbitan solution, water
Label text from the FDA structured product label by Softgel Healthcare Private Limited (revised Jan 28, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 2 products
- Doxylamine Succinate in 2 products
- Dextromethorphan Hydrobromide in 2 products
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 35916-0154 | Acetaminophen 325 mg/1; Doxylamine Succinate 6.25 mg/1; Dextromethorphan Hydrobromide 15 mg/1 Capsule, Liquid Filled | Softgel Healthcare Private Limited | OTC MONOGRAPH DRUG |
| 35916-0189 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Doxylamine Succinate 6.25 mg/1 Capsule, Liquid Filled | SOFTGEL HEALTHCARE PRIVATE LIMITED | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate used for?
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing
Who makes Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate?
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate is listed by 2 labelers in the FDA NDC directory, including Softgel Healthcare Private Limited, SOFTGEL HEALTHCARE PRIVATE LIMITED.