Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 9f533092-060c-4379-9a77-ecfea8aa46e1

Route

ORAL

Published

Effective Date 2024-04-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg)

Inactive Ingredients

Acesulfame Potassium Alcohol Trisodium Citrate Dihydrate Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Maltitol Water Sodium Benzoate Sodium Citrate, Unspecified Form Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-03-31

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg

Uses

temporarily relieves these common cold due to
- minor aches and pains
- headache
- nasal and sinus congestion
- sore throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever

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
blister
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 is 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 6 doses (180 mL) in any 24-hours peroid
measure only with dosing cup provided. Do not use any other dosing device
mL = milliliter
keep dosing cup with product
adults and children 12 years and over
- 30 mL every 4 hours
children under 12 years of age: 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 Severe Cold & Cough Berry Flavor

Other Information

each 30 mL contains: sodium 16 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients

acesulfame potassium, alcohol, citric acid, disodium EDTA, FD&C blue #1 FD&C red #40, , flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate sodium citrate

Questions Or Comments?

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

Principal Display Panel

Compare to Theraflu® ExpressMax® Daytime Severe Cold & Cough active ingredients*

DAYTIME

Severe Cold & Cough

Acetaminophen 650 mg /

Pain Reliever/Fever Reducer

Dextromethorphan HBr 20 mg /

Cough Suppressant

Phenylephrine HCl 10 mg/

Nasal Decongestant

Flu & Severe Cold

Nasal Congestion
Fever
Cough
Sore Throat
Headache
Body Ache

Alcohol 10%

For Ages 12 Years & Over

Berry Flavor

FL OZ (mL)

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® ExpressMax® Daytime Severe Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF PRINITED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

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

nervousness, dizziness, or sleeplessness occur
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.

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 (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms

Active Ingredients (in Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have

liver disease
heart disease
thyroid disease
diabetes
high blood pressure
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If User Is

taking the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves these common cold due to
- minor aches and pains
- headache
- nasal and sinus congestion
- sore throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever

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
blister
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 is 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 6 doses (180 mL) in any 24-hours peroid
measure only with dosing cup provided. Do not use any other dosing device
mL = milliliter
keep dosing cup with product
adults and children 12 years and over
- 30 mL every 4 hours
children under 12 years of age: 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.

Product Label

H-E-B Daytime Severe Cold & Cough Berry Flavor

Other Information (Other information)

each 30 mL contains: sodium 16 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, alcohol, citric acid, disodium EDTA, FD&C blue #1 FD&C red #40, , flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate sodium citrate

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

Compare to Theraflu® ExpressMax® Daytime Severe Cold & Cough active ingredients*

DAYTIME

Severe Cold & Cough

Acetaminophen 650 mg /

Pain Reliever/Fever Reducer

Dextromethorphan HBr 20 mg /

Cough Suppressant

Phenylephrine HCl 10 mg/

Nasal Decongestant

Flu & Severe Cold

Nasal Congestion
Fever
Cough
Sore Throat
Headache
Body Ache

Alcohol 10%

For Ages 12 Years & Over

Berry Flavor

FL OZ (mL)

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® ExpressMax® Daytime Severe Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF PRINITED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

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)

nervousness, dizziness, or sleeplessness occur
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.

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.)

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

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

liver disease
heart disease
thyroid disease
diabetes
high blood pressure
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If User Is (Ask a doctor or pharmacist before use if user is)

taking the blood thinning drug warfarin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold due to minor aches and pains headache nasal and sinus congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces fever", "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 blister 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 is 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 6 doses (180 mL) in any 24-hours peroid measure only with dosing cup provided. Do not use any other dosing device mL = milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours children under 12 years of age: 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 Severe Cold & Cough Berry Flavor", "Other information": "each 30 mL contains: sodium 16 mg store between 20-25ºC (68-77ºF). Do not refrigerate.", "Inactive ingredients": "acesulfame potassium, alcohol, citric acid, disodium EDTA, FD&C blue #1 FD&C red #40, , flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate sodium citrate", "Questions or comments?": "Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "Compare to Theraflu® ExpressMax® Daytime Severe Cold & Cough active ingredients* DAYTIME Severe Cold & Cough Acetaminophen 650 mg / Pain Reliever/Fever Reducer Dextromethorphan HBr 20 mg / Cough Suppressant Phenylephrine HCl 10 mg/ Nasal Decongestant Flu & Severe Cold Nasal Congestion Fever Cough Sore Throat Headache Body Ache Alcohol 10% For Ages 12 Years & Over Berry Flavor FL OZ (mL) *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® ExpressMax® Daytime Severe Cold & Cough. TAMPER EVIDENT: DO NOT USE IF PRINITED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. 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": "nervousness, dizziness, or sleeplessness occur 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.", "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 (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms", "Active ingredients (in each 30 mL)": "Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg", "Ask a doctor before use if you have": "liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema", "Ask a doctor or pharmacist before use if user is": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:56.943714 · Updated: 2026-03-14T23:02:46.668637