Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Phenylephrine Hydrochloride 5mg Capsules (minis, Ultra-concentrated, Orange)

Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Phenylephrine Hydrochloride 5mg Capsules (minis, Ultra-concentrated, Orange)
SPL v4
SPL
SPL Set ID 30ab39f3-27cc-5728-e063-6394a90a9cbe
Route
ORAL
Published
Effective Date 2026-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Dextromethorphan (10 mg) Acetaminophen (325 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Water Sorbitan Mica Polyethylene Glycol 400 Glycerin Sorbitol Titanium Dioxide Povidone K30 Gelatin Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Shape: oval Color: orange Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-21

Description

Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Phenylephrine HCl USP 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Phenylephrine HCl USP 5 mg

Uses

• temporarily relieves these symptoms due to a cold or flu:

• minor aches and pains • headache • cough

•sore throat • nasal and sinus congestion

•temporarily reduces fever

Section 50567-7

When using this product do not exceed recommended dosage

Section 51945-4

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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 or severe allergic 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.

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 10 capsules in 24 hours or as directed by a doctor.
  • children under 12 years: 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

Other Information

● store at room temperature. Avoid excessive heat above 40ºC (104ºF).

Inactive Ingredients

FD&C yellow no.5, FD&C yellow no.6, gelatin, glycerin, mica, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution, titanium dioxide

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
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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes

● cough with excessive phlegm (mucus)

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Active Ingredients (in Each Softgelatin Capsule)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Phenylephrine HCl USP 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin


Structured Label Content

Uses

• temporarily relieves these symptoms due to a cold or flu:

• minor aches and pains • headache • cough

•sore throat • nasal and sinus congestion

•temporarily reduces fever

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 51945-4 (51945-4)

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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 or severe allergic 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.

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 10 capsules in 24 hours or as directed by a doctor.
  • children under 12 years: do not use
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

Other Information (Other information)

● store at room temperature. Avoid excessive heat above 40ºC (104ºF).

Inactive Ingredients (Inactive ingredients)

FD&C yellow no.5, FD&C yellow no.6, gelatin, glycerin, mica, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution, titanium dioxide

Stop Use and Ask A Doctor If (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
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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes

● cough with excessive phlegm (mucus)

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Active Ingredients (in Each Softgelatin Capsule) (Active ingredients (in each softgelatin capsule))

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Phenylephrine HCl USP 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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