Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7

Route

ORAL

Published

Effective Date 2025-03-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Saccharin Sodium Trisodium Citrate Dihydrate Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-05-31

Description

Acetaminophen 325 mg Dextromethoprhan HBr 10 mg

Purpose

Pain reliever/fever reducer Cough suppressant

Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant

Description

Acetaminophen 325 mg Dextromethoprhan HBr 10 mg

Uses

temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever

Purposes

Pain reliever/fever reducer

Cough suppressant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount for this product
child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks everyday while using this product

Allery 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 any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL=milliliter

adults and children 12 years and over	30 mL every 4 hours
children 6 to under 12 years	15 mL every 4 hours
children 4 to under 6 years	ask a doctor
children under 4 years	do not use

When using Day Time and Night Time products, carefully read each label to ensure correct dosing

Do Not Use

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.
if you are allergic to acetaminophen
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.

Package Label

CVS HEALTH Daytime Cold & Flu

Other Information

each 15 mL contains: sodium 12 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients

citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

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

Principal Display Panel

DAYTIME

COLD & FLU

ACETAMINOPHEN 325 mg

Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr 10 mg

Cough suppressant

MULTI-SYMPTOM RELIEF

Relieves:

Aches, Fever, Sore throat, Cough

No added alcohol

See New Drug Facts

FL OZ (mL)

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

When Using This Product,

do not exceed recommended dosage.

Stop Use and Ask A Doctor If

pain, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
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 as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 15 Ml)

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Ask A Doctor Before Use If You Have

liver disease
a breathing problem such as emphysema or chronic bronchitis
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)

Ask A Doctor Or Pharmacist Before Use If the User Is

taking the blood thinning drug warfarin.

Structured Label Content

Uses

temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever

Purposes

Pain reliever/fever reducer

Cough suppressant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount for this product
child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks everyday while using this product

Allery 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 any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL=milliliter

adults and children 12 years and over	30 mL every 4 hours
children 6 to under 12 years	15 mL every 4 hours
children 4 to under 6 years	ask a doctor
children under 4 years	do not use

When using Day Time and Night Time products, carefully read each label to ensure correct dosing

Do Not Use (Do not use)

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.
if you are allergic to acetaminophen
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.

Package Label

CVS HEALTH Daytime Cold & Flu

Other Information (Other information)

each 15 mL contains: sodium 12 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, 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

DAYTIME

COLD & FLU

ACETAMINOPHEN 325 mg

Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr 10 mg

Cough suppressant

MULTI-SYMPTOM RELIEF

Relieves:

Aches, Fever, Sore throat, Cough

No added alcohol

See New Drug Facts

FL OZ (mL)

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
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 15 Ml) (Active ingredients (in each 15 mL))

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

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

liver disease
a breathing problem such as emphysema or chronic bronchitis
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)

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

taking the blood thinning drug warfarin.

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "325", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough due to minor throat and bronchial irritation temporarily reduces fever", "Purposes": "Pain reliever/fever reducer Cough suppressant", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount for this product child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Allery 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 any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL=milliliter adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing", "Do not use": "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. if you are allergic to acetaminophen 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.", "Package Label": "CVS HEALTH Daytime Cold & Flu", "Other information": "each 15 mL contains : sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.", "Inactive ingredients": "citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "DAYTIME COLD & FLU ACETAMINOPHEN 325 mg Pain reliever; Fever reducer DEXTROMETHORPHAN HBr 10 mg Cough suppressant MULTI-SYMPTOM RELIEF Relieves: Aches, Fever, Sore throat, Cough No added alcohol See New Drug Facts FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895", "When using this product,": "do not exceed recommended dosage .", "Stop use and ask a doctor if": "pain, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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 as well as for children even if you do not notice any signs or symptoms.", "Active ingredients (in each 15 mL)": "Acetaminophen 325 mg Dextromethoprhan HBr 10 mg", "Ask a doctor before use if you have": "liver disease a breathing problem such as emphysema or chronic bronchitis 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)", "Ask a doctor or pharmacist before use if the user is": "taking the blood thinning drug warfarin."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:19.718963 · Updated: 2026-03-14T23:07:58.892866