c8e9b57b-83e9-46c5-9791-02c4c2b94004
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each tablespoonful 15 mL) Acetaminophen 325 mg Diphenhydramine HCL 12.5 mg Phenylephrine HCL 5mg
Purpose
Pain reliever/Fever reducer Cough suppressant/Antihistamine Nasal decongestant
Medication Information
Purpose
Pain reliever/Fever reducer
Cough suppressant/Antihistamine
Nasal decongestant
Description
Active ingredients (in each tablespoonful 15 mL) Acetaminophen 325 mg Diphenhydramine HCL 12.5 mg Phenylephrine HCL 5mg
Uses
temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal and sinus congestion
- runny nose
- sneezing
- itchy watery eyes
- itchy nose or throat
- cough due to minor throat and bronchial irritation as may occur with a cold
- temporarily reduces fever
Warnings
Liver warnings: This product contains acetaminophen.
Severe liver damage may occur if you take:
- more than 6 dose in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Directions
Age Dose
Children under 4 years Do not use
Children 4 to under 12 years of age Do not use unless directed by a doctor
Adults and children 12 years and over 2 tablespoonful (30 mL) every 4 hours
- take only as recommended (see Overdose warning)
- use dose cup or tablespoon (TBSP)
- do not take more than 6 doses in any 24-hour period
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.
- if you are taking a prescription monamine 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 drug containing diphenhydramine, even one used on the skin
- for children under 4 years of age
Questions?
Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Product Label
NDC 6801-154-08
*COMPARE TO THE ACTIVE INGREDIENTS IN THERAFUL® WARMING RELIEF COLD AND CHEST CONGESTION
Premier Value®
Night Time Severe Cold and Cough Relief
Acetaminophen ............ Pain Reliever/Fever Reducer
Diphenhydramine.......... Antihistamine/Cough Suppressant
Phenylephrine HCL ...... Nasal Congestion
Fever and Body Aches
Sore Throat
Headache
Nasal Congestion
Runny Nose
Cough
Cherry Flavor
8.3 FL OZ (245 mL)
PV Independently Tested Satisfaction Guaranteed
LF-007
DO NOT USE IF PRINTED SEAL UNDER AP IS TORN OR MISSING
Failure to follow these warnings could result in consequences
LB-007
DISTRIBUTED BY CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD SUITE 101
BOCA RATON, FL 33431
Lot:
Exp:
*This product is not manufactured or distributed b Novartis Consumer health Inc., owner of the registered trademark Theraflu® Night Time
Overdose Warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact the Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other Information
- each tablespoon (15 mL) contains: potassium 9 mg, sodium 6 mg
- dosage cup provided
- store between 20°-25° C (68°-7°7 F)
- do not refrigerate
Inactive Ingredients
Acesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and C Red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate
When Using This Product
- do not use more than directed (see overdose warning)
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcohol drinks
- be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
- nervousness, dizziness or sleeplessness occur
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
Drug Facts Active Ingredients
Active ingredients
(in each tablespoonful 15 mL)
Acetaminophen 325 mg
Diphenhydramine HCL 12.5 mg
Phenylephrine HCL 5mg
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
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or empysema
- cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are Taking
- the blood thinning drug warfarin
- sedatives or tranquilizers
Structured Label Content
Uses
temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal and sinus congestion
- runny nose
- sneezing
- itchy watery eyes
- itchy nose or throat
- cough due to minor throat and bronchial irritation as may occur with a cold
- temporarily reduces fever
Purpose
Pain reliever/Fever reducer
Cough suppressant/Antihistamine
Nasal decongestant
Warnings
Liver warnings: This product contains acetaminophen.
Severe liver damage may occur if you take:
- more than 6 dose in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Directions
Age Dose
Children under 4 years Do not use
Children 4 to under 12 years of age Do not use unless directed by a doctor
Adults and children 12 years and over 2 tablespoonful (30 mL) every 4 hours
- take only as recommended (see Overdose warning)
- use dose cup or tablespoon (TBSP)
- do not take more than 6 doses in any 24-hour period
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.
- if you are taking a prescription monamine 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 drug containing diphenhydramine, even one used on the skin
- for children under 4 years of age
Questions?
Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Product Label
NDC 6801-154-08
*COMPARE TO THE ACTIVE INGREDIENTS IN THERAFUL® WARMING RELIEF COLD AND CHEST CONGESTION
Premier Value®
Night Time Severe Cold and Cough Relief
Acetaminophen ............ Pain Reliever/Fever Reducer
Diphenhydramine.......... Antihistamine/Cough Suppressant
Phenylephrine HCL ...... Nasal Congestion
Fever and Body Aches
Sore Throat
Headache
Nasal Congestion
Runny Nose
Cough
Cherry Flavor
8.3 FL OZ (245 mL)
PV Independently Tested Satisfaction Guaranteed
LF-007
DO NOT USE IF PRINTED SEAL UNDER AP IS TORN OR MISSING
Failure to follow these warnings could result in consequences
LB-007
DISTRIBUTED BY CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD SUITE 101
BOCA RATON, FL 33431
Lot:
Exp:
*This product is not manufactured or distributed b Novartis Consumer health Inc., owner of the registered trademark Theraflu® Night Time
Overdose Warning (Overdose warning)
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact the Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other Information (Other information)
- each tablespoon (15 mL) contains: potassium 9 mg, sodium 6 mg
- dosage cup provided
- store between 20°-25° C (68°-7°7 F)
- do not refrigerate
Inactive Ingredients (Inactive ingredients)
Acesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and C Red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate
When Using This Product (When using this product)
- do not use more than directed (see overdose warning)
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcohol drinks
- 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
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
Drug Facts Active Ingredients (Drug facts Active ingredients)
Active ingredients
(in each tablespoonful 15 mL)
Acetaminophen 325 mg
Diphenhydramine HCL 12.5 mg
Phenylephrine HCL 5mg
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)
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
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or empysema
- cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if you are taking)
- the blood thinning drug warfarin
- sedatives or tranquilizers
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Source: dailymed · Ingested: 2026-02-15T12:05:07.585896 · Updated: 2026-03-14T23:06:27.679265