drug facts

drug facts

SPL v1

SPL

SPL Set ID 11027431-c536-4242-a995-58c2227c0479

Route

oral

Published

Effective Date 2014-10-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

acetaminophen (325 mg) dextromethorphan (10 mg) phenylephrine (5 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 active Since 2007-08-22

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Medication Information

Warnings

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

more than 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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.

Uses

temporarily relieves
- minor aches and pains
- headache
- minor sore throat pain
- nasal congestion
- cough due to minor throat and bronchial irritation
- temporarily reduces fever

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Directions

do not use in infants
do not exceed recommended dose (see overdose warning)
use dosage cup provided
tbsp = tablespoon, mL = milliliter

age	dose
adults and children 12 years and over	2 tablespoons (30 mL) every 4 hours
children 4 to 11 years	do not use unless directed by a doctor
children under 4 years	do not use

Do not take more than 6 doses (12 tablespoons) in 24 hours.

Other Information

each 15 mL contains: sodium 8 mg
store at room temperature

Inactive Ingredients

acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Principal Display Panel

Daytime

Flu Relief Therapy

SEVERE COLD

Pain Reliever / Fever Reducer - Acetaminophen

Cough Suppressant - Dextromethorphan HBr

Nasal Decongestant - Phenylephrine HCl

Nasal Congestion • Sore Throat • Headache • Body Ache • Cough • Fever

*Compare to active ingredients in Theraflu®

Distributed by: SELECT BRAND DISTRIBUTORS

Pine Bluff, AR 71603 USA AC (870) 535-3635

Alcohol Content: 10%

Cherry Flavor

FL OZ (mL)

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

Failure to follow the drug facts warnings could result in serious consequences.

PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® Daytime.

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.
with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Product Label

Select Brand Flu Relief Therapy Daytime Severe Cold Cherry Liquid

Questions Or Comments?

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

When Using This Product,

do not use more than directed (see overdose warning)

Stop Use and Ask A Doctor If

redness or swelling is present
new symptoms occur
nervousness, dizziness, or sleeplessness occurs
fever gets worse or lasts more than 3 days
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs with a fever, 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) immediately. 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
heart disease
diabetes
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
cough accompanied by excessive phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Active Ingredients (in Each 15 Ml, 1 Tablesoon)

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

Warnings

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

more than 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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.

Uses

temporarily relieves
- minor aches and pains
- headache
- minor sore throat pain
- nasal congestion
- cough due to minor throat and bronchial irritation
- temporarily reduces fever

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Directions

do not use in infants
do not exceed recommended dose (see overdose warning)
use dosage cup provided
tbsp = tablespoon, mL = milliliter

age	dose
adults and children 12 years and over	2 tablespoons (30 mL) every 4 hours
children 4 to 11 years	do not use unless directed by a doctor
children under 4 years	do not use

Do not take more than 6 doses (12 tablespoons) in 24 hours.

Other Information (Other information)

each 15 mL contains: sodium 8 mg
store at room temperature

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Principal Display Panel

Daytime

Flu Relief Therapy

SEVERE COLD

Pain Reliever / Fever Reducer - Acetaminophen

Cough Suppressant - Dextromethorphan HBr

Nasal Decongestant - Phenylephrine HCl

Nasal Congestion • Sore Throat • Headache • Body Ache • Cough • Fever

*Compare to active ingredients in Theraflu®

Distributed by: SELECT BRAND DISTRIBUTORS

Pine Bluff, AR 71603 USA AC (870) 535-3635

Alcohol Content: 10%

Cherry Flavor

FL OZ (mL)

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

Failure to follow the drug facts warnings could result in serious consequences.

PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® Daytime.

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.
with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Product Label

Select Brand Flu Relief Therapy Daytime Severe Cold Cherry Liquid

Questions Or Comments? (Questions or comments?)

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

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

do not use more than directed (see overdose warning)

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

redness or swelling is present
new symptoms occur
nervousness, dizziness, or sleeplessness occurs
fever gets worse or lasts more than 3 days
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs with a fever, 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.)

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

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

Active Ingredients (in Each 15 Ml, 1 Tablesoon) (Active ingredients (in each 15 mL, 1 tablesoon))

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

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains headache minor sore throat pain nasal congestion 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 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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 use in infants do not exceed recommended dose (see overdose warning ) use dosage cup provided tbsp = tablespoon, mL = milliliter age dose adults and children 12 years and over 2 tablespoons (30 mL) every 4 hours children 4 to 11 years do not use unless directed by a doctor children under 4 years do not use Do not take more than 6 doses (12 tablespoons) in 24 hours.", "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. with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product", "Product Label": "Select Brand Flu Relief Therapy Daytime Severe Cold Cherry Liquid", "Other information": "each 15 mL contains: sodium 8 mg store at room temperature", "Inactive ingredients": "acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate", "Questions or comments?": " Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "Daytime Flu Relief Therapy SEVERE COLD Pain Reliever / Fever Reducer - Acetaminophen Cough Suppressant - Dextromethorphan HBr Nasal Decongestant - Phenylephrine HCl Nasal Congestion • Sore Throat • Headache • Body Ache • Cough • Fever *Compare to active ingredients in Theraflu® Distributed by: SELECT BRAND DISTRIBUTORS Pine Bluff, AR 71603 USA AC (870) 535-3635 Alcohol Content: 10% Cherry Flavor FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE CAP IS BROKEN OR MISSING. Failure to follow the drug facts warnings could result in serious consequences. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® Daytime.", "When using this product,": "do not use more than directed (see overdose warning)", "Stop use and ask a doctor if": "redness or swelling is present new symptoms occur nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with a fever, 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) immediately. 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 heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland cough accompanied by excessive phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema", "Active ingredients (in each 15 mL, 1 tablesoon)": "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:54.828232 · Updated: 2026-03-14T22:53:57.959732