Drug Facts
c24b9489-208c-472b-8ae5-c6e86c12e04d
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 650 mg Diphenhydramine HCl 25 mg
Purpose
Pain reliever/Fever reducer Antihistamine/Cough suppressant
Medication Information
Purpose
Pain reliever/Fever reducer Antihistamine/Cough suppressant
Description
Acetaminophen 650 mg Diphenhydramine HCl 25 mg
Uses
- temporarily relieves these symptoms to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- runny nose
- sneezing
- itchy nose or throat
- itchy, watery eyes due to hay fever
- cough due to minor throat and bronchial irritation
- 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
- take every 4 hours in dosing cup provided, while symptoms persist
- do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor
|
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.
- with any other product containing diphenhydramine, even one used on the skin
- to sedate a child or make a child sleepy
Other Information
Distributed by: Haleon, Warren, NJ 07059 Made in Mexico Trademarks are owned by or licensed to the Haleon group of companies. ©2024 Haleon group of companies or its licensor. Pat. Info www.productpats.com
PEEL BACK HERE
DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.
Other Information
- each 30 mL contains:potassium 30 mg, sodium 13 mg
- store at controlled room temperature 20°-25°C (68° – 77°F)
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate
Questions Or Comments?
1-855-328-5259
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
- 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.
Active Ingredients (in Each 30 Ml)
Acetaminophen 650 mg
Diphenhydramine HCl 25 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
Package/label Principal Display Panel
MULTI-SYMPTOM COLD RELIEF
THERAFLU
SEVERE
COLD RELIEF
NIGHTTIME
Acetaminophen
Pain Reliever/Fever Reducer
Diphenhydramine HCl
Antihistamine/Cough Suppressant
HELPS YOU REST*
Powerful formula that relieves:
/ Cough
/ Sore throat pain
/ Head and body ache
/ Fever
/ Runny nose
/ Sneezing
8.3 FL OZ (245.5 mL)
Berry Flavor
*Temporarily controls cough to help you rest. This is not a sleep-aid.
Ask A Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
Structured Label Content
Uses
- temporarily relieves these symptoms to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- runny nose
- sneezing
- itchy nose or throat
- itchy, watery eyes due to hay fever
- cough due to minor throat and bronchial irritation
- 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
- take every 4 hours in dosing cup provided, while symptoms persist
- do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor
|
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.
- with any other product containing diphenhydramine, even one used on the skin
- to sedate a child or make a child sleepy
Other Information
Distributed by: Haleon, Warren, NJ 07059 Made in Mexico Trademarks are owned by or licensed to the Haleon group of companies. ©2024 Haleon group of companies or its licensor. Pat. Info www.productpats.com
PEEL BACK HERE
DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.
Other Information (Other information)
- each 30 mL contains:potassium 30 mg, sodium 13 mg
- store at controlled room temperature 20°-25°C (68° – 77°F)
Inactive Ingredients (Inactive ingredients)
acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate
Questions Or Comments? (Questions or comments?)
1-855-328-5259
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)
- 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.)
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 650 mg
Diphenhydramine HCl 25 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
Package/label Principal Display Panel (Package/Label Principal Display Panel)
MULTI-SYMPTOM COLD RELIEF
THERAFLU
SEVERE
COLD RELIEF
NIGHTTIME
Acetaminophen
Pain Reliever/Fever Reducer
Diphenhydramine HCl
Antihistamine/Cough Suppressant
HELPS YOU REST*
Powerful formula that relieves:
/ Cough
/ Sore throat pain
/ Head and body ache
/ Fever
/ Runny nose
/ Sneezing
8.3 FL OZ (245.5 mL)
Berry Flavor
*Temporarily controls cough to help you rest. This is not a sleep-aid.
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:13.204146 · Updated: 2026-03-14T23:10:28.026216