Drug Facts
780907b8-34ba-4ec8-bcdf-b2a31bd111df
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 1000 mg Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg
Purpose
Pain reliever/Fever reducer Antihistamine Cough suppressant
Medication Information
Purpose
Pain reliever/Fever reducer Antihistamine Cough suppressant
Description
Acetaminophen 1000 mg Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg
Uses
- temporarily relieves these symptoms due to a common cold:
- headache
- minor aches and pains
- cough due to minor throat and bronchial irritation
- minor sore throat pain
- runny nose
- temporarily reduces fever
Purposes
Pain reliever/Fever reducer
Antihistamine
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
- measure the dose correctly using the enclosed dosing cup
- adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist
- do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor
- children under 12 years of age: do not use
|
Age |
Dose |
|
adults and children 12 years of age and over |
30 mL |
|
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.
Other Information
- each 30 mL contains: potassium 5 mg, sodium 34 mg
- store at controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, glycerin, nautral and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate
Additional Information
DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD. USE AS DIRECTED
PEEL BACK HERE
DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.
*Maximum Strength per 6 hour dose.
PARENTS:Learn about teen medicine abuse
www.StopMedicineAbuse.org
Questions Or Comments?
1-855-328-5259
Principal Display Panel
THERAFLU
FLU RELIEF
MAX STRENGTH*
NIGHTTIME
Acetaminophen
Pain Reliever/Fever Reducer
Chlorpheniramine Maleate
Antihistamine
Dextromethorphan HBr
Cough Suppressant
HELPS YOU REST**
Powerful fever fighting formula that relieves:
/ Body ache
/ Headache
/ Sore throat pain
/ Cough
/ Runny nose
Honey & Elderberry Flavor
8.3 FL OZ (245.5 mL)
When Using This Product
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use and Ask A Doctor If
- pain 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.
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.
Active Ingredients (in Each 30 Ml)
Acetaminophen 1000 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg
Ask A Doctor Before Use If You Have
- liver disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Structured Label Content
Uses
- temporarily relieves these symptoms due to a common cold:
- headache
- minor aches and pains
- cough due to minor throat and bronchial irritation
- minor sore throat pain
- runny nose
- temporarily reduces fever
Purposes
Pain reliever/Fever reducer
Antihistamine
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
- measure the dose correctly using the enclosed dosing cup
- adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist
- do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor
- children under 12 years of age: do not use
|
Age |
Dose |
|
adults and children 12 years of age and over |
30 mL |
|
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.
Other Information (Other information)
- each 30 mL contains: potassium 5 mg, sodium 34 mg
- store at controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)
anhydrous citric acid, carboxymethylcellulose sodium, glycerin, nautral and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate
Additional Information
DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD. USE AS DIRECTED
PEEL BACK HERE
DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.
*Maximum Strength per 6 hour dose.
PARENTS:Learn about teen medicine abuse
www.StopMedicineAbuse.org
Questions Or Comments? (Questions or comments?)
1-855-328-5259
Principal Display Panel
THERAFLU
FLU RELIEF
MAX STRENGTH*
NIGHTTIME
Acetaminophen
Pain Reliever/Fever Reducer
Chlorpheniramine Maleate
Antihistamine
Dextromethorphan HBr
Cough Suppressant
HELPS YOU REST**
Powerful fever fighting formula that relieves:
/ Body ache
/ Headache
/ Sore throat pain
/ Cough
/ Runny nose
Honey & Elderberry Flavor
8.3 FL OZ (245.5 mL)
When Using This Product (When using this product)
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- pain 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.)
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.
Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))
Acetaminophen 1000 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- liver disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
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
- taking sedatives or tranquilizers
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:07:21.310352 · Updated: 2026-03-14T23:10:42.831626