Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 91dbb541-6a86-4803-a1fe-1bf61b457c34

Route

ORAL

Published

Effective Date 2024-06-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg)

Inactive Ingredients

Calcium Gluconate Monohydrate Carboxymethylcellulose Calcium Carnauba Wax Corn Syrup Crospovidone, Unspecified Fd&c Red No. 40 Aluminum Oxide Fd&c Yellow No. 6 Glycerin Mannitol Starch, Corn Sodium Gluconate Sorbitol Sorbitol Solution Sucralose Sucrose Cow Milk

Identifiers & Packaging

Pill Appearance

Imprint: T Shape: round Color: red Size: 21 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-06-19

Description

Acetaminophen 325 mg Dextromethorphan equivalent to 10 mg Dextromethorphan HBr

Purpose

Pain reliever/Fever reducer Cough suppressant

Medication Information

Purpose

Pain reliever/Fever reducer Cough suppressant

Description

Acetaminophen 325 mg Dextromethorphan equivalent to 10 mg Dextromethorphan HBr

Uses

▪
temporarily relieves these symptoms due to a cold:
- ▪
  minor aches and pains
- ▪
  sore throat pain
- ▪
  headache
- ▪
  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 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 use more than directed
▪
do not take more than 10 chewable tablets in 24 hours unless directed by a doctor. Take every 4 hours, while symptoms persist.

Age	Dose
adults and children 12 years of age and over	take 2 chewable tablets every 4 hours
children under 12 years of age	do not use

Do Not Use

▪
in a child under 12 years of age
▪
if you are allergic to acetaminophen
▪
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.

Generic Section

Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION” is broken or missing.

Distributed by: Haleon, Warren, NJ 07059

Trademarks are owned by or licensed to the Haleon group of companies.

Pat. Info www.productpats.com

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

211433

56047666

Peel Here

Other Information

▪
each chewable tablet contains: potassium 10 mg, sodium 6 mg
▪
store at a controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients

calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk

Questions Or Comments?

call 1-855-328-5359

Stop Use and Ask A Doctor If

▪
fever gets worse or lasts more than 3 days
▪
redness or swelling is present
▪
new symptoms occur
▪
pain or cough gets worse or lasts more than 7 days
▪
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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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
▪
cough that occurs with too much phlegm (mucus)
▪
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Package/label Principal Display Panel

NEW

THERAFLU

SEVERE COLD RELIEF

SOFT CHEWS

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

FAST relief ANYWHERE

cough / sore throat / headache / body aches / fever

20 CHEWABLE TABLETS

Chew tablets completely before swallowing

Apple Cinnamon Flavor

Active Ingredients (in Each Chewable Tablet)

Acetaminophen 325 mg

Dextromethorphan equivalent to 10 mg Dextromethorphan HBr

Ask A Doctor Or Pharmacist Before Use If You Are

▪
taking the blood thinning drug warfarin

Structured Label Content

Uses

▪
temporarily relieves these symptoms due to a cold:
- ▪
  minor aches and pains
- ▪
  sore throat pain
- ▪
  headache
- ▪
  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 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 use more than directed
▪
do not take more than 10 chewable tablets in 24 hours unless directed by a doctor. Take every 4 hours, while symptoms persist.

Age	Dose
adults and children 12 years of age and over	take 2 chewable tablets every 4 hours
children under 12 years of age	do not use

Do Not Use (Do not use)

▪
in a child under 12 years of age
▪
if you are allergic to acetaminophen
▪
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.

Generic Section

Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION” is broken or missing.

Distributed by: Haleon, Warren, NJ 07059

Trademarks are owned by or licensed to the Haleon group of companies.

Pat. Info www.productpats.com

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

211433

56047666

Peel Here

Other Information (Other information)

▪
each chewable tablet contains: potassium 10 mg, sodium 6 mg
▪
store at a controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

call 1-855-328-5359

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

▪
fever gets worse or lasts more than 3 days
▪
redness or swelling is present
▪
new symptoms occur
▪
pain or cough gets worse or lasts more than 7 days
▪
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.)

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

▪
liver disease
▪
cough that occurs with too much phlegm (mucus)
▪
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NEW

THERAFLU

SEVERE COLD RELIEF

SOFT CHEWS

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

FAST relief ANYWHERE

cough / sore throat / headache / body aches / fever

20 CHEWABLE TABLETS

Chew tablets completely before swallowing

Apple Cinnamon Flavor

Active Ingredients (in Each Chewable Tablet) (Active ingredients (in each chewable tablet))

Acetaminophen 325 mg

Dextromethorphan equivalent to 10 mg Dextromethorphan HBr

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 these symptoms due to a cold: ▪ minor aches and pains ▪ sore throat pain ▪ headache ▪ 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 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 use more than directed ▪ do not take more than 10 chewable tablets in 24 hours unless directed by a doctor. Take every 4 hours, while symptoms persist. Age Dose adults and children 12 years of age and over take 2 chewable tablets every 4 hours children under 12 years of age do not use", "Do not use": "▪ in a child under 12 years of age ▪ if you are allergic to acetaminophen ▪ 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.", "Generic Section": "Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION” is broken or missing. Distributed by: Haleon, Warren, NJ 07059 Trademarks are owned by or licensed to the Haleon group of companies. Pat. Info www.productpats.com ©2024 Haleon group of companies or its licensor. PARENTS: Learn about teen medicine abuse. www.StopMedicineAbuse.org 211433 56047666 Peel Here", "Other information": "▪ each chewable tablet contains: potassium 10 mg, sodium 6 mg ▪ store at a controlled room temperature 20-25°C (68-77°F)", "Inactive ingredients": "calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk", "Questions or comments?": "call 1-855-328-5359", "Stop use and ask a doctor if": "▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ pain or cough gets worse or lasts more than 7 days ▪ 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.": "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 ▪ cough that occurs with too much phlegm (mucus) ▪ cough that lasts or is chronic such as occurs with smoking, asthma or emphysema", "Package/Label Principal Display Panel": "NEW THERAFLU SEVERE COLD RELIEF SOFT CHEWS Acetaminophen Pain Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant FAST relief ANYWHERE cough / sore throat / headache / body aches / fever 20 CHEWABLE TABLETS Chew tablets completely before swallowing Apple Cinnamon Flavor", "Active ingredients (in each chewable tablet)": "Acetaminophen 325 mg Dextromethorphan equivalent to 10 mg Dextromethorphan HBr", "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: 2026-02-15T12:03:10.384297 · Updated: 2026-03-14T23:03:06.131630