Acetaminophen 325 Mg, Dextromethorphan Hbr 10 Mg, Doxylamine Succinate 6.25 Mg Capsules (night Severe)

Acetaminophen 325 Mg, Dextromethorphan Hbr 10 Mg, Doxylamine Succinate 6.25 Mg Capsules (night Severe)
SPL v4
SPL
SPL Set ID 353f71f7-81e0-08c2-e063-6294a90acb49
Route
ORAL
Published
Effective Date 2026-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: green Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-17

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Antihistamine


Medication Information

Purpose

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing

Section 51945-4

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.

Directions
  • take only as directed
  • do not exceed 8 softgels per 24 hrs
adults & children 12 yrs & over 2 softgels with water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs 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.
Other Information
  • do not exceed 25ºC
Inactive Ingredients

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone K-30, propylene glycol, purified water, sorbitol sorbitan solution

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 If
  • you get nervous, dizzy or sleepless
  • 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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
  • 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
Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

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

Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing

Section 51945-4 (51945-4)

Purpose

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

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.

Directions
  • take only as directed
  • do not exceed 8 softgels per 24 hrs
adults & children 12 yrs & over 2 softgels with water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs 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.
Other Information (Other information)
  • do not exceed 25ºC
Inactive Ingredients (Inactive ingredients)

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone K-30, propylene glycol, purified water, sorbitol sorbitan solution

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 If (Stop use and ask a doctor if)
  • you get nervous, dizzy or sleepless
  • 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.

If Pregnant 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.

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 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
Active Ingredients (in Each Softgel) (Active ingredients (in each Softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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