equatetm

equatetm
SPL v2
SPL
SPL Set ID 38637189-d1ee-9405-e063-6394a90ae8b8
Route
oral
Published
Effective Date 2025-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg) doxylamine (6.25 mg) phenylephrine (5 mg)
Inactive Ingredients
d&c yellow no. 10 fd&c blue no. 1 gelatin, unspecified glycerin polyethylene glycol, unspecified povidone, unspecified propylene glycol sorbitol sorbitan titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-09-10

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg


Medication Information

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.

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.

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

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

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, and tranquilizers may increase drowsiness

Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • pain, nasal congestion, 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.

Uses

• temporarily relieves common cold/flu symptoms:

  • nasal congestion • sinus congestion & pressure

  • cough due to minor throat & bronchial irritation

  • cough to help you sleep • minor aches & pains

  • headache • fever • sore throat

• runny nose & sneezing

• reduces swelling of nasal passages

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

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

Other Information

• store at controlled room temperature 20-25°C (68-77°F)  • protect from light, heat, and moisture

Inactive Ingredients

D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Section 42229-5

Compare to Vicks® NyQuil™ Severe Cold & Flu LiquiCaps™ active ingredients*

Relief of:

• Headache, fever, sore throat, minor aches and pains

• Nasal/sinus congestion and sinus pressure

• Sneezing, runny nose

• Cough

Satisfaction Guaranteed

For more information call 1-888-287-1915 or visit Walmart.com/help

DISTRIBUTED BY:

Walmart Inc.,

Bentonville, AR 72716

PRODUCT OF INDIA

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks® NyQuil™ LiquiCaps™.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TEMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OR TAMPERING.

Section 50565-1

Keep out of reach of children, 

Overdose warning:
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.

Packaging

Drug Facts

Active Ingredients

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Questions Or Comments?

1-888-287-1915


Structured Label Content

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.

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.

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

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

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, and tranquilizers may increase drowsiness

Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • pain, nasal congestion, 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.

Uses

• temporarily relieves common cold/flu symptoms:

  • nasal congestion • sinus congestion & pressure

  • cough due to minor throat & bronchial irritation

  • cough to help you sleep • minor aches & pains

  • headache • fever • sore throat

• runny nose & sneezing

• reduces swelling of nasal passages

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

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

Other Information (Other information)

• store at controlled room temperature 20-25°C (68-77°F)  • protect from light, heat, and moisture

Inactive Ingredients (Inactive ingredients)

D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide

Section 42229-5 (42229-5)

Compare to Vicks® NyQuil™ Severe Cold & Flu LiquiCaps™ active ingredients*

Relief of:

• Headache, fever, sore throat, minor aches and pains

• Nasal/sinus congestion and sinus pressure

• Sneezing, runny nose

• Cough

Satisfaction Guaranteed

For more information call 1-888-287-1915 or visit Walmart.com/help

DISTRIBUTED BY:

Walmart Inc.,

Bentonville, AR 72716

PRODUCT OF INDIA

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks® NyQuil™ LiquiCaps™.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TEMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OR TAMPERING.

Section 50565-1 (50565-1)

Keep out of reach of children, 

Overdose warning:
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.

Packaging

Drug Facts

Active Ingredients (Active ingredients)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Questions Or Comments? (Questions or comments?)

1-888-287-1915


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)