Medicine guide

Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

5 mg + 325 mg + 10 mg · Capsule, Liquid Filled

Available without prescription
Sigma-1 Agonist

Active substance: Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
Used in: Breathing, airways, allergies and cough
Made by: SOFTGEL HEALTHCARE PRIVATE LIMITED
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-01-28

What it is

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Used for

Nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

How to take it

Adults & children 12 years & over 2 Softgels with water every 4 hours

Full directions ↓

Do not take it if

With any other drug containing acetaminophen (prescription or nonprescription).

All warnings ↓

Good to know

Sold without a prescription
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

1other products contain Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Temporarily relieves common cold/flu symptoms:

nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

From the official label · 2026-01-28 · DailyMed

Do not take it if

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.

Quoted from the official label, section “OTC — Do Not Use”.

How to take it

These directions are for this exact strength and form. Another one is different.

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

Quoted from the official label, section “Dosage & Administration”.

Ask a doctor first if

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

Quoted from the official label, section “OTC — Ask Doctor”.

Ask a pharmacist first if

you are taking the blood thinning drug warfarin.

Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.

Stop and get help 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.

Quoted from the official label, section “OTC — Stop Use”.

Other 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 more than directed.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Keep away from 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.

Quoted from the official label, section “OTC — Keep Out of Reach of Children”.

Other information

store at no greater than 25°C

Quoted from the official label, section “OTC — Other Information”.

What kind of medicine it is

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution.

Quoted from the official label, section “Inactive Ingredients”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Colour dyesFD&C Red No. 40; FD&C Yellow No. 6Some people react to dyes such as tartrazine (Yellow 5) or carmine.
Sugar alcoholssorbitol sorbitan solutionSorbitol and similar can upset the stomach and matter with fructose intolerance.
GelatingelatinAnimal-derived: matters for vegetarian, vegan, halal and kosher diets.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (2)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 2 of 2

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (16)

Details

Made by	SOFTGEL HEALTHCARE PRIVATE LIMITED
Active substance	Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
Used in	Breathing, airways, allergies and cough
Strength	5 mg + 325 mg + 10 mg
Form	Capsule, Liquid Filled
Route	Oral
Packs	4 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK · 2 POUCH in 1 CARTON / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
NDC	35916-0155
NDC	35916-0917

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Capsule, Liquid Filled2 products
- 5 mg + 325 mg + 10 mg2
  5 mg + 325 mg + 10 mg · 2 companies
  - Prodose, Inc.
  - SOFTGEL HEALTHCARE PRIVATE LIMITED · this page

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride5 mg + 325 mg + 10 mgWithout prescriptionCapsule, Liquid Filled Prodose, Inc. · Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

See every product with Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride