Acetaminophen 325 Mg, Dextromethorphan Hydrobromide 15mg And Doxylamine Succinate 6.25 Mg Softgelatin Capsules (night Time)

Acetaminophen 325 Mg, Dextromethorphan Hydrobromide 15mg And Doxylamine Succinate 6.25 Mg Softgelatin Capsules (night Time)
SPL v2
SPL
SPL Set ID 229d1939-84a9-f18e-e063-6394a90aba30
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) Doxylamine (6.25 mg) Dextromethorphan (15 mg)
Inactive Ingredients
Glycerin Sorbitol Water Gelatin Povidone Polyethylene Glycol 400 D&c Yellow No. 10 Propylene Glycol Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: green Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-27

Description

Acetaminophen USP 325 mg Dextromethorphan HBr USP 15 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 15 mg Doxylamine succinate USP 6.25 mg

Uses

temporarily relieves common cold/flu symptoms:

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

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 6 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.
Tamper Evident

This package is safety-sealed. Use only if blisters are intact. If difficult to open, use scissors.

Manufactured By

Softgel Healthcare Pvt Ltd.,

Survey no. 20/1, Vandalur-Kelambakkam Road,

Pudupakkam Village, Kancheepuram District,

Tamilnadu – 603103, India

Mfg. Lic. No: xxxxxxxxxxxxxx

Other Information
  • store at no greater than 25ºC
Inactive Ingredients

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

Principal Display Panel

NDC Code: 35916-0154-1

*Compared to the active ingredient in VICKS ® NyQuil TM Cold & F Liquicaps TM

Acetaminophen 325 mg, Dextromethorphan Hbr 15 mg and Doxylamine Succinate 6.25 mg Softgelatin Capsules

Fever, Sore Throat, Headache, Minor Aches & Pains

Runny Nose & Sneezing

Cough

Night time

(Cold & Flu - 12 Softgels)

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
  • pain 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.

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.

Active Ingredients(in Each Softgel)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 15 mg

Doxylamine succinate USP 6.25 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • 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
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
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing

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 6 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.
Tamper Evident (TAMPER EVIDENT)

This package is safety-sealed. Use only if blisters are intact. If difficult to open, use scissors.

Manufactured By (Manufactured by)

Softgel Healthcare Pvt Ltd.,

Survey no. 20/1, Vandalur-Kelambakkam Road,

Pudupakkam Village, Kancheepuram District,

Tamilnadu – 603103, India

Mfg. Lic. No: xxxxxxxxxxxxxx

Other Information (Other information)
  • store at no greater than 25ºC
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC Code: 35916-0154-1

*Compared to the active ingredient in VICKS ® NyQuil TM Cold & F Liquicaps TM

Acetaminophen 325 mg, Dextromethorphan Hbr 15 mg and Doxylamine Succinate 6.25 mg Softgelatin Capsules

Fever, Sore Throat, Headache, Minor Aches & Pains

Runny Nose & Sneezing

Cough

Night time

(Cold & Flu - 12 Softgels)

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)
  • pain 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.

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.

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

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 15 mg

Doxylamine succinate USP 6.25 mg

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