Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 12ace982-bd47-49b0-ba1b-e0a29d42f1d6
Route
ORAL
Published
Effective Date 2024-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Butylated Hydroxyanisole Butylated Hydroxytoluene Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitan Sorbitol D&c Yellow No. 10 Sodium Metabisulfite Carminic Acid

Identifiers & Packaging

Pill Appearance
Imprint: P19;95A;512;P119 Shape: capsule Color: orange Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-05-31

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains 
    • headache
    • sore throat
    • nasal congestion
    • fever
    • cough due to minor throat and bronchial irritation
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

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
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
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.
Product Label
H-E-B DayTime Cold & Flu
Other Information
  • store between 15-30ºC (59-86ºF)
  • avoid excessive heat
Inactive Ingredients

butylated hydroxyanisole, butylated hydroxytoluene, carminic acid*, D&C yellow #10*,edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol*, povidone, propylene glycol, purified water, metabisulfite*,sorbitan, sorbitol

*may contain this ingredient

Questions Or Comments?

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to  Vicks® DayQuil® Cold & Flu active ingredients**

Daytime

Acetaminophen / Pain Reliever / Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Phenylephrine HCl / Nasal Decongestant

Cold & Flu

Non-Drowsy

Multi-Symptom

Relief of:

  • Pain
  • Fever
  • Cough
  • Allergy Symptoms

SOFTGELS†

(†LIQUID-FILLED CAPSULES)

†This product is not manufactured or distributed by The Procter & Gamble Company, Vicks®, DayQuil®, are registered trademarks of The Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204

When Using This Product,

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • nervousness, dizziness or sleeplessness occur 
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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.

Overdose warning: Taking more than the recommended dose can cause liver damage. 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
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Uses
  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains 
    • headache
    • sore throat
    • nasal congestion
    • fever
    • cough due to minor throat and bronchial irritation
Purpose

Pain reliever/fever reducer

Cough suppressant

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

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
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
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.
Product Label
H-E-B DayTime Cold & Flu
Other Information (Other information)
  • store between 15-30ºC (59-86ºF)
  • avoid excessive heat
Inactive Ingredients (Inactive ingredients)

butylated hydroxyanisole, butylated hydroxytoluene, carminic acid*, D&C yellow #10*,edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol*, povidone, propylene glycol, purified water, metabisulfite*,sorbitan, sorbitol

*may contain this ingredient

Questions Or Comments? (Questions or comments?)

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to  Vicks® DayQuil® Cold & Flu active ingredients**

Daytime

Acetaminophen / Pain Reliever / Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Phenylephrine HCl / Nasal Decongestant

Cold & Flu

Non-Drowsy

Multi-Symptom

Relief of:

  • Pain
  • Fever
  • Cough
  • Allergy Symptoms

SOFTGELS†

(†LIQUID-FILLED CAPSULES)

†This product is not manufactured or distributed by The Procter & Gamble Company, Vicks®, DayQuil®, are registered trademarks of The Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204

When Using This Product, (When using this product,)

do not exceed recommended dosage.

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
  • new symptoms occur
  • nervousness, dizziness or sleeplessness occur 
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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.)

Overdose warning: Taking more than the recommended dose can cause liver damage. 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
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 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.


Advanced Ingredient Data


Raw Label Data

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