Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID fcb23436-7a62-4338-83b1-7b3755b58616
Route
ORAL
Published
Effective Date 2023-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Diphenhydramine (25 mg) Phenylephrine (10 mg)
Inactive Ingredients
Acesulfame Potassium Alcohol Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Maltitol Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Completed Since 2015-10-31 Until 2025-10-31
Description

Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer Antihistamine / Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer Antihistamine / Cough suppressant Nasal decongestant

Description

Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

Uses
  • temporarily relieves these symptoms due to a cold
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
    • itchy,watery eyes due to hay fever
    • nasal and sinus congestion
    • itchy of the nose or throat 
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Purposes

Pain reliever/fever reducer

Antihistamine /

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 6 doses in any 24-hour period
  • 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
  • to make a child sleepy
  • 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.
  • with any other product containing diphenhydramine, even one used on skin
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Product Label
H-E-B Nighttime Severe Cold & Cough
Other Information
  • each 30 mL contains: potassium 10 mg
  • each 30 mL contains: sodium 14 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients

acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, 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® Nighttime Severe Cold & Cough active ingredients*

NIGHTTIME

Severe Cold & Cough

Acetaminophen / Pain Reliever / Fever Reducer

Diphenhydramine / Antihistamine / Cough Suppressant

Phenylephrine HCl / Nasal Decongestant

Flu & Severe Cold

  • Nasal Congestion,
  • Fever,
  • Cough,
  • Sore Throat,
  • Runny Nose,
  • Headache,
  • Body Ache

Alcohol 10%

For Ages 12 Years & Over

Cherry Flavor

FL OZ (mL)

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

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

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

When Using This Product
  • do not exceed recommended dosage
  • alcohol, sedative, and tranquilizers may increase drowsiness
  • avoid alcohol drinks
  • be careful when driving a motor vehicle or operating machinery
  • marked drowsiness may occur 
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occurs
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • new symptoms 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 (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 as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 30 Ml)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • glaucoma
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are Taking
  • the blood thinning drug warfarin
  • sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves these symptoms due to a cold
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
    • itchy,watery eyes due to hay fever
    • nasal and sinus congestion
    • itchy of the nose or throat 
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Purposes

Pain reliever/fever reducer

Antihistamine /

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 6 doses in any 24-hour period
  • 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)
  • to make a child sleepy
  • 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.
  • with any other product containing diphenhydramine, even one used on skin
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Product Label
H-E-B Nighttime Severe Cold & Cough
Other Information (Other information)
  • each 30 mL contains: potassium 10 mg
  • each 30 mL contains: sodium 14 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, 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® Nighttime Severe Cold & Cough active ingredients*

NIGHTTIME

Severe Cold & Cough

Acetaminophen / Pain Reliever / Fever Reducer

Diphenhydramine / Antihistamine / Cough Suppressant

Phenylephrine HCl / Nasal Decongestant

Flu & Severe Cold

  • Nasal Congestion,
  • Fever,
  • Cough,
  • Sore Throat,
  • Runny Nose,
  • Headache,
  • Body Ache

Alcohol 10%

For Ages 12 Years & Over

Cherry Flavor

FL OZ (mL)

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

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

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
  • alcohol, sedative, and tranquilizers may increase drowsiness
  • avoid alcohol drinks
  • be careful when driving a motor vehicle or operating machinery
  • marked drowsiness may occur 
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occurs
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • new symptoms 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 (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 as well as for children even if you do not notice any signs or symptoms.

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

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • glaucoma
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if you are taking)
  • the blood thinning drug warfarin
  • sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:33.338182 · Updated: 2026-03-14T23:01:01.701433