Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID 37896933-3ed3-457f-8a32-ee0d784a19e8

Route

ORAL

Published

Effective Date 2024-07-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Diphenhydramine (25 mg) Phenylephrine (10 mg)

Inactive Ingredients

Fd&c Blue No. 1 Glycerin Propylene Glycol Water Sorbitol Anhydrous Citric Acid Fd&c Red No. 40 Propyl Gallate Sodium Benzoate Sodium Citrate Sucralose Xanthan Gum Edetate Calcium Disodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-06-30

Description

Acetaminophen 650 mg Diphenhydramine HCI 25 mg Phenylephrine HCI 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 HCI 25 mg Phenylephrine HCI 10 mg

Uses

temporarily relieves these common cold and flu symptoms
- cough
- nasal congestion
- minor ache and pains
- sore throat
- headache
- runny nose
- sneezing
temporarily reduces fever
controls cough to help you get to sleep

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 hours period
measure only with dosing cup provided. Do not use any other dosing device
keep dosing cup with product
mL = milliliter
dose as follows or as directed by a doctor
adults and children 12 years and older :
- 20 mL every 4 hours while symptoms last
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.
with any other drug containing diphenhydramine even one used on the skin
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.
for children under 12 years of age

Product Label

WALGREENS Nighttime Cold & Flu

Other Information

each 20 mL contains: sodium 12 mg
store between 20-25ºC (68-77F). Do not refrigerate

Inactive Ingredients

citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

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

Principal Display Panel

Compare to the active ingredient in Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu††

NIGHTTIME

Cold & Flu

ACETAMINOPHEN / PAIN RELIEVER & FEVER REDUCER

DIPHENHYDRAMINE HCI / ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCI / NASAL DECONGESTANT

MAXIMUM STRENGTH

Relieves aches, fever & sore throat, nasal congestion, runny nose & sneezing
Controls cough
12 years & older

FL OZ (mL)

††This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademarks Mucinex® and Fast-Max®.

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

DISTRIBUTED BY : WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

When Using This Product

do not use more than directed
excitability may occur, especially in children
avoid alcoholic drinks
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
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.

Keep Out of Reach of Children.

Overdose warning: Taking more than the recommended dose (overdose) can 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 20 Ml)

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg

Phenylephrine HCI 10 mg

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

you are taking the blood thinning drug warfarin
you are taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves these common cold and flu symptoms
- cough
- nasal congestion
- minor ache and pains
- sore throat
- headache
- runny nose
- sneezing
temporarily reduces fever
controls cough to help you get to sleep

Purpose

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 hours period
measure only with dosing cup provided. Do not use any other dosing device
keep dosing cup with product
mL = milliliter
dose as follows or as directed by a doctor
adults and children 12 years and older :
- 20 mL every 4 hours while symptoms last
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.
with any other drug containing diphenhydramine even one used on the skin
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.
for children under 12 years of age

Product Label

WALGREENS Nighttime Cold & Flu

Other Information (Other information)

each 20 mL contains: sodium 12 mg
store between 20-25ºC (68-77F). Do not refrigerate

Inactive Ingredients (Inactive ingredients)

citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

Compare to the active ingredient in Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu††

NIGHTTIME

Cold & Flu

ACETAMINOPHEN / PAIN RELIEVER & FEVER REDUCER

DIPHENHYDRAMINE HCI / ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCI / NASAL DECONGESTANT

MAXIMUM STRENGTH

Relieves aches, fever & sore throat, nasal congestion, runny nose & sneezing
Controls cough
12 years & older

FL OZ (mL)

††This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademarks Mucinex® and Fast-Max®.

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

DISTRIBUTED BY : WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

When Using This Product (When using this product)

do not use more than directed
excitability may occur, especially in children
avoid alcoholic drinks
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
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, (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 20 Ml) (Active ingredients (in each 20 mL))

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg

Phenylephrine HCI 10 mg

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

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

you are taking the blood thinning drug warfarin
you are taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold and flu symptoms cough nasal congestion minor ache and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep", "Purpose": "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 hours period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL = milliliter dose as follows or as directed by a doctor adults and children 12 years and older : 20 mL every 4 hours while symptoms last 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. with any other drug containing diphenhydramine even one used on the skin 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. for children under 12 years of age", "Product Label": "WALGREENS Nighttime Cold & Flu", "Other information": "each 20 mL contains: sodium 12 mg store between 20-25ºC (68-77F). Do not refrigerate", "Inactive ingredients": "citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum", "Questions or comments?": " Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "Compare to the active ingredient in Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu†† NIGHTTIME Cold & Flu ACETAMINOPHEN / PAIN RELIEVER & FEVER REDUCER DIPHENHYDRAMINE HCI / ANTIHISTAMINE / COUGH SUPPRESSANT PHENYLEPHRINE HCI / NASAL DECONGESTANT MAXIMUM STRENGTH Relieves aches, fever & sore throat, nasal congestion, runny nose & sneezing Controls cough 12 years & older FL OZ (mL) ††This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademarks Mucinex® and Fast-Max®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY : WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com", "When using this product": "do not use more than directed excitability may occur, especially in children avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur 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.", "Keep out of reach of children.": "Overdose warning : Taking more than the recommended dose (overdose) can 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 20 mL)": "Acetaminophen 650 mg Diphenhydramine HCI 25 mg Phenylephrine HCI 10 mg ", "Ask a doctor before use if you have": "liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus)", "Ask a doctor or pharmacist before use if you are": "you are taking the blood thinning drug warfarin you are taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:18.044743 · Updated: 2026-03-14T23:03:17.077951