Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg & Doxylamine Succinate 6.25 Mg Capsules (minis, Ultra-concentrated, Green)

Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg & Doxylamine Succinate 6.25 Mg Capsules (minis, Ultra-concentrated, Green)
SPL v2
SPL
SPL Set ID 2f7f078e-de04-9d53-e063-6394a90a409f
Route
ORAL
Published
Effective Date 2026-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Blue No. 1 1,4-sorbitan Mica Polyethylene Glycol 400 Povidone K30 D&c Yellow No. 10 Sorbitol Glycerin Gelatin Titanium Dioxide Water

Identifiers & Packaging

Pill Appearance
Shape: oval Color: green Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-04

Description

Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Doxylamine Succinate USP 6.25 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Description

Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Doxylamine Succinate USP 6.25 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 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 53414-9

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

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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).

Bulk Package Label

Inactive Ingredients

D&C yellow no.10, FD&C blue no.1, 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.

Ask A Doctor Before Use If You Have

• liver disease • heart disease • high blood pressure

• thyroid disease • diabetes

• cough that occurs 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 Capsule)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Doxylamine Succinate USP 6.25 mg


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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 53414-9 (53414-9)

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

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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

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

Bulk Package Label (Bulk package Label)

Inactive Ingredients (Inactive ingredients)

D&C yellow no.10, FD&C blue no.1, 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.

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 that occurs 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 Capsule) (Active Ingredients (in each capsule))

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Doxylamine Succinate USP 6.25 mg


Advanced Ingredient Data


Raw Label Data

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