Acetaminophen 325 Mg , Dextromethorphan Hydrobromide 10 Mg, Doxylamine Succinate 6.25 Mg And Phenylephrine Hydrochloride 5 Mg (night Mini Green)

Acetaminophen 325 Mg , Dextromethorphan Hydrobromide 10 Mg, Doxylamine Succinate 6.25 Mg And Phenylephrine Hydrochloride 5 Mg (night Mini Green)
SPL v3
SPL
SPL Set ID 36ced59c-12dc-441f-e063-6294a90a3239
Route
ORAL
Published
Effective Date 2026-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Titanium Dioxide Mica Water D&c Yellow No. 10 Glycerin Gelatin Fd&c Blue No. 1 Polyethylene Glycol 400 Povidone K30 Sorbitol

Identifiers & Packaging

Pill Appearance
Shape: oval Color: green Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-11

Description

Acetaminophen USP 325 mg Dextromethorphan Hydrobromide USP 10 mg Doxylamine Succinate USP 6.25 mg Phenylephrine Hydrochloride USP 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Description

Acetaminophen USP 325 mg Dextromethorphan Hydrobromide USP 10 mg Doxylamine Succinate USP 6.25 mg Phenylephrine Hydrochloride USP 5 mg

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
Section 50565-1

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.

Section 51945-4

Section 53414-9

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

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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 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.

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
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 15ºC- 25ºC (59º-77ºF)

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

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 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
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
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

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

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
Section 50565-1 (50565-1)

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.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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 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.

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
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 15ºC- 25ºC (59º-77ºF)

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

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 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
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
  • 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
Active Ingredients (in Each Capsule) (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

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
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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